The meeting, scheduled for 2:30 p.m. and held virtually, came on the heels of the governor contracting COVID-19 earlier in the month. It was his second time receiving a positive test.

DeWine confirmed during the conference that he was 10 days out from initially contracting the virus. He added that he took another COVID-19 test prior to attending, and it came back negative.

"My experience was fairly light, candidly," DeWine said; "I had been vaccinated several times before, and I took the drugs that were prescribed as soon as I was diagnosed with it, and frankly, have had a pretty easy time. I feel good."

The ODH director and governor noted that data is showing high-risk populations, such as people who are 60 and older, are being hospitalized the most by the virus.

"We're still losing two people a day, who are dying from COVID," DeWine. "Getting the vaccine is certainly the best thing you can do and give the best chance of not getting really sick once you get it."

Over the course of the summer, Ohio saw COVID-19 cases sink to record lows for 2023. The state had less than 2,000 new cases per week heading into June. More recently in the course of September, cases trended upward before falling back down. the Ohio Department of Health reported Thursday that the state had 7,721 new cases in the past week. Comparatively, it saw 8,224 cases from Sept. 15 through Sept. 21 and neared 10,000 in the week prior.

Hospitalizations have also risen through September before falling, with the latest report showing 255 compared to 312 patients during the week of Sept. 15. Deaths climbed consistently, with ODH reporting 33 compared to 28 in the week prior.

Still, the pair of speakers did not see any kind of coronavirus public safety protocols coming back anytime soon.

"I don't see that we're going to be imposing any kind of mask mandates," DeWine said. "The vaccine is readily available."

Molnupiravir, known commercially as Lagevrio, is one of two COVID-19 antivirals authorized for treating coronavirus infections along with Paxlovid from Pfizer. The drug works by inducing mutations in the virus's cells as it replicates, resulting in random mutations that are harmful to the virus and cuts down on its viral load.

Researchers from the U.K. and South Africa delved into the question of where some mutated variants may have occurred, given that some have been found with seemingly random mutations, and whether molnupiravir may have contributed to the rise of some strains.

In the study published in the Nature Science Journal, researchers looked at available data from patients who were treated with molnupiravir and those who were not. Their findings confirmed the drug's ability to cause high rates of mutations in the virus, and they noted that a "high proportion" of these mutations are likely to be hazardous to the virus.

They also looked at sequenced COVID-19 genomes from global databases and narrowed down mutations that were only sequenced in 2022, after molnupiravir became available, and found that many of the sequences were consistent with mutations that were found in patients treated with the antiviral.

They cited a specific type of mutation that rarely occurs in natural SARS-CoV-2 evolution but which they note is induced through the use of molnupiravir. High rates of the specific mutation that researchers associated with molnupiravir use were found in populations of countries where the use of the treatment was higher, such as in seniors in Australia where retirement homes were stocked with the drug.

The study put forward that molnupiravir may increase genomic diversity in the viral cells that survive the hazardous mutations brought on by the drug, expanding the variety from which SARS-CoV-2 can select from for future changes.

"Importantly, the divergence of the molnupiravir mutation spectrum from standard SARS-CoV-2 mutational dynamics might allow the virus to explore the fitness of distinctive parts of the possible genomic landscape to those it is already widely exploring in the general population," the study stated.

"Molnupiravir-induced mutation could also potentially allow infections to persist for longer by creating a more varied target for the immune system."

When reached for comment, Merck questioned the strength of the evidence presented by the researchers.

"The authors assume these mutations were associated with viral spread from molnupiravir-treated patients without documented evidence of that transmission. Instead, the authors rely on circumstantial associations between the region from which the sequence was identified and timeframe of sequence collection in countries where molnupiravir is available to draw their conclusions," said the company.

"Furthermore, these sequences were uncommon and were associated with sporadic cases. As noted by the authors, there are limitations to the analyses conducted in this study, which are described in more detail in the manuscript," Merck added. "These data must be considered in the context of all available clinical and non-clinical molnupiravir data."

People can go to COVIDtests.gov to place their order for four rapid at-home tests per household, which will be delivered for free by the United States Postal Service.

Once your order ships, you should get a tracking number sent to the email you include with your order.

This is the fifth round of free at-home tests delivered by USPS. The Postal Service has delivered 755 million tests in previous rounds.

It's not clear how long the window to order new tests will be open, though the Department of Health and Human Services told the Associated Press it would be up for several months.

Dawn O’Connell, assistant secretary for preparedness and response at HHS, said the website will remain functional to receive orders through the holidays, and “we reserve the right to keep it open even longer if we're starting to see an increase in cases.”

“If there is a demand for these tests, we want to make sure that they're made available to the American people for free in this way,” O'Connell said. “But, at this point, our focus is getting through the holidays and making sure folks can take a test if they're going to see Grandma for Thanksgiving."

The government first launched the site in January of 2022 but stopped taking orders in June 2023 to help stockpile a federal supply of the tests, according to CNBC.

Now, twelve manufacturers in seven states from California to Maryland have been awarded funding and will produce 200 million over-the-counter tests to replenish federal supplies for government use. Those manufacturers will also be producing enough tests to meet demand for tests ordered online, the HHS said.

The tests are designed to detect COVID variants currently circulating and are intended for use by the end of the year. However, they will include instructions on how to verify extended expiration dates, the department said.

The Associated Press contributed to this report.

Millions of the newly formulated vaccines have shipped out since the Centers for Disease Control and Prevention signed off on them last week for ages 6 months and up. Cases started rising again in late summer, and experts hope that the new shots will help protect people during the upcoming fall respiratory virus season.

But some people have had to cancel appointments because their insurance hasn’t updated the billing codes to cover the vaccines. Others signed up for an appointment, only to have it canceled due to supply issues. And in some places, there are no available nearby vaccines: A search in Juneau, Alaska, through the federal government’s website shows no available appointments within 100 miles.

Some pharmacies have a limited supply of the shots, Alaska Department of Health spokesperson Alex Huseman said, but order backlogs and slow shipments have prevented the vaccines from being widely available. Private health care providers hopefully can get them as early as next week, she said.

“This rollout has been a little bumpier than anticipated, but we do not believe there will be any significant delay in vaccine availability,” Huseman said.

This is the first time that the vaccines are reaching most Americans through the commercial market, bringing public and private health insurers back in the mix. Previously, the federal government bought and distributed COVID-19 vaccines for free since they became available.

CVS Pharmacy spokesperson Matt Blanchette said some insurers are still in the process of updating their billing systems to cover the vaccines. For others, the shots were covered by insurance without issue, but appointments were canceled by their pharmacy due to supply delays.

Walgreens and CVS confirmed that delivery delays to some stores across the country had led to canceled appointments.

“We are aware of isolated incidences at a small number of locations where appointments had to be rescheduled due to delays in supply,” a Walgreens spokesperson said, noting most stores “have supply to support existing patient appointments.”

Moderna and Pfizer representatives told The Associated Press that they have enough supply. Pfizer spokespeople said it is not experiencing any shortages and has “shipped and delivered several million doses of its 2023-2024 COVID-19 vaccine.” Moderna had six million available as of Thursday, vice president of communications Chris Ridley said.

Marwa Bakr, the owner of a small, private pharmacy on Milwaukee’s southwest side, said she put in a preorder for Pfizer and Moderna’s new vaccines a month ago. She got a call from Moderna this week telling her she should get the vaccines in the next two weeks, and Pfizer has said the shots could come by the end of next week.

She used to order the vaccines through the federal government, and said the return to the commercial process is “taking longer.”

“I receive a lot of phone calls every day from people asking when the vaccine will be available,” Bakr said.

Still, the supply issues aren’t deterring people from looking for the vaccine.

Karen Ramos of Temecula, California, made an appointment at her local CVS as soon as she heard that the vaccines were approved. The 57-year-old insurance underwriter has never had COVID-19 — at least, as far as she is aware. She wanted to keep it that way ahead of a scheduled Caribbean cruise on Oct. 1.

She had scheduled an appointment last Saturday, but the day before, she got a text from the pharmacy saying the new vaccine was not available and her appointment had been canceled. She set a new appointment for Tuesday, which also was canceled “due to unforeseen circumstances.”

Ramos started searching for appointments at any CVS between her home and office in San Diego. By expanding her search to Walgreens, she was able to snag an appointment in Temecula on Tuesday.

“It was frustrating, because I was excited to get it two weeks in advance (of the cruise), and then having to scramble to reschedule,” she said.

___

The Associated Press Health and Science Department receives support from the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

The website COVIDtests.gov will be back up on Sept. 25 and will allow each American household to order four free tests.

"We think it's really important to prevent the spread of COVID for people to be able to test to know whether they have it or not,” U.S. Dept. of Health and Human Services Assistant Secretary for Preparedness and Response Dawn O'Connell said.

O’Connell says the tests will come from the federal stockpile that they’ve built up.

The Biden administration is also paying $600 million to various U.S. manufacturers to produce more COVID tests for future use. O’Connell calls it a strategic investment meant to strengthen our own supply chains.

"To have this domestic manufacturing capability and investing our dollars now in that, to have COVID tests when we need them but also to be able to manufacture future tests,” O’Connell said.

But people’s attitudes about the virus have changed, and so have the precautions they are taking.

Dr. Amesh Adalja with Johns Hopkins Center for Health Security says that isn’t a surprise.

"As people have risk acclimatized to COVID19 their urgency to test or to get paxlovid or to get up to date on their vaccines has fallen,” Adalja.

As immunity wanes and people move indoors with the changing seasons, he predicts we could see another COVID uptick.

"The way we make it something that doesn't disrupt our lives is to use the tools that science and medicine have given us to make our lives easier to navigate in a world where COVID is an ever present threat."

Even if there is less public concern, the Biden administration believes their efforts will help reduce the spread

“What's important to us is that we make the tool available. We think that it's a critically important arrow that we have in our quiver to protect the American people,” O’Connell said.

When it comes to prevention, Dr. Adalja says convenience does make a difference.

“The easier it is for people to test and to know their status, the easier it is for them to take the correct action,” Adalja said.

He also says the updated COVID booster will be an important tool for fighting the virus, especially for high-risk individuals.

“Certainly, we're not going to fund them,” he said in an interview with ABC. “I think that Biden is spending billions and billions of dollars on these. So they've done studies. They have not demonstrated the benefit of the boosters.”

DeSantis, who remains a strong opponent of mandating COVID-19 vaccines and other pandemic measures, claimed that there isn't enough research to show whether the benefits of the new boosters outweigh the potential risks. 

President Biden said last month that he plans to ask for more funding from Congress for the development of a new coronavirus vaccine — a move that could face hurdles as a similar request to combat the virus was blocked by Congress last year. 

“I signed off this morning on a proposal we have to present to the Congress a request for additional funding for a new vaccine that is necessary, that works,” Biden said at the time.

DeSantis also questioned whether the Centers for Disease Control and Prevention (CDC) should be trusted, vowing to hold the agency “accountable” if elected in 2024. He claimed the CDC misrepresented how effective masking and vaccines were in preventing COVID-19 infections during the height of the pandemic, saying that the agency cited “flimsy” studies. 

“They would make representations which were not true. So the trust that's been lost, I think has been incalculable and one of the things that I said is when I come in we're going to have a reckoning about all these COVID policies," he said. "We're going to hold people accountable, who got it wrong."

A new COVID-19 booster was rolled out last week after the Food and Drug Administration (FDA) approved the new shots, which are meant to protect new strains of the coronavirus and are recommended for everyone older than 6 months.

However, the campaign to get people vaccinated is off to a rocky start as the federal government scrambles to make the shots accessible to uninsured Americans.

DeWine tested positive for the virus Tuesday, just hours after speaking at a news conference with state and city leaders -- during which he coughed and looked fatigued. As of Wednesday, a spokesperson said he was resting at home as he was experiencing symptoms.

COVID hospitalizations have increased statewide, and doctors in central Ohio say that trend is being seen locally, too. Once the newest version of the COVID vaccine is available, Dr. Christina Liscynesky -- a physician and associate professor of internal medicine at Wexner Medical Center -- said it is important Ohioans stay updated on their vaccines.

“COVID is clearly not as bad as it was in the beginning, but it is still causing issues,” Liscynesky said.

Liscynesky, who specializes in infectious diseases, said she has noticed an uptick in COVID patients at the hospital. She said she isn’t concerned, however, about hospitals becoming overwhelmed again -- but some patients are at higher risk.

“Around our cancer hospital and what I've been seeing, there are patients who have gotten b cell depleting therapy or something called Rituxan, and have not been up to date with their COVID vaccines,” she said. “They are having a harder time getting rid of the COVID.”

The Food and Drug Administration approved the newest COVID booster on Sept. 12, and Liscynesky said it's vital people get the jab.

“With time and with the way that our immunity builds up, hybrid immunity through vaccination as well as infection, we will continue to have less and less severe symptoms,” she said.

The latest shot will be most necessary for people who are immunocompromised or anyone who is around someone who is immunocompromised.

“In particular for our cancer patients, because they are getting treated for their cancer and their cancer therapy needs to go on as scheduled in order to treat the cancer,” she said. “The problem is that we have patients who don't have good immune systems, who aren't able to form these antibodies or these surveillance systems, and those people can still get severe COVID.”

But it is hit or miss whether the newest COVID booster -- against the XBB variant -- is available yet in central Ohio.

Both Columbus Public Health and the Licking County Health Department said they have ordered the vaccine and are waiting for it to come in. Franklin County Public Health said it does have the newest vaccine in stock, but is waiting for guidelines from the CDC on how to distribute it.

The Ohio Department of Health said it is slowly starting to receive the new vaccines for some programs.

The rollout process has changed since the government allowed the public health emergency to expire in May. The government used to be the sole provider of the vaccine. Now providers can purchase the vaccine directly from manufacturers.

As for the general public, the Ohio Department of Health said it did not have a date for when the vaccine will be available.

Reports are piling up of insured Americans being stuck with the nearly $200 bill for shots, which were approved last week. The new vaccines are designed to protect against new strains of the coronavirus and are recommended for everyone older than 6 months. 

While the Biden administration has scrambled to make the shots accessible to uninsured Americans, it’s unclear whether current supply will meet demand. 

Anyone with health insurance — either through private insurers or federal programs like Medicare and Medicaid — should be able to receive the new COVID vaccines for free. 

But that’s not always happening, according to news reports and complaints on social media. As CBS News reported, the vaccines have new billing codes, and insurers are still updating their plans to cover the shots.

Major health insurance providers, including Blue Cross Blue Shield, Aetna and Kaiser Permanente, said they planned to cover the COVID-19 shots as routine vaccinations when reached for comment by The Hill. Providers like Cigna and Anthem did not immediately respond when reached for comment or deferred inquiries to AHIP, the health insurance trade association.

“Health insurance providers are working with the federal government and pharmacy and provider partners to ensure that everyone has access to ACIP-recommended vaccines, without cost sharing,” AHIP said in a statement to The Hill. 

“The new vaccine formulations mark the first time that the COVID-19 vaccines are available without being purchased/distributed by the federal government.”

Health and Human Services Secretary Xavier Becerra received his updated COVID shot at a CVS Pharmacy in Washington on Wednesday to encourage vaccine uptake and promote the availability of vaccines through pharmacies. 

While taking questions from reporters, Becerra acknowledged accounts of insured individuals having to pay out-of-pocket. The secretary said any claims that insurers aren’t covering the shots are “not correct.”

“Please make sure you're talking to your insurance company because. You should be covered by law. If you are insured, you are covered for COVID. If you are on Medicare, you are covered. If you are on Medicaid, you are covered and if you don't have insurance — through this Bridge Access program — you are covered,” Becerra said.

He also encouraged insured customers to speak with their pharmacists because they may be able to clear up any confusion.

“We've contacted the insurers and contacted the pharmacists and we're working with them to make sure everyone understands how this works,” Becerra said.

For the uninsured, the Biden administration has quickly expanded pathways to deliver COVID-19 vaccinations. The initiative, called the Bridge Access Program, will distribute vaccines through community health centers, local health departments and pharmacies. 

There were initial concerns that contracts with pharmacies in the Bridge program — CVS, Walgreens and eTrueNorth — might not be finalized until October, but the CDC announced last week that existing contracts had been modified to offer the shots in areas with low coverage and access.

HHS estimates more than 20,000 retail pharmacy locations across the U.S. will offer no-cost vaccinations through this Bridge program, scheduled to run until December 2024.

But community health centers and local health departments are also adjusting to a COVID response without the federal funds they enjoyed during the pandemic to help administer doses.

According to Lori Freeman, CEO of the National Association of County and City Health Officials (NACCHO), health centers lack both the resources and the supply that they previously benefited from.

“There will be about 6 million vaccines available and those initial vaccines are targeted towards the uninsured and underinsured folks through what is called the Bridge Program,” Freeman said. 

“Three million will be available to state and local health departments through federally qualified health centers and through the regional community health centers. And so there's going to be less vaccines and there are about 25 million total uninsured people in the country right now. So you can easily do the math.”

Health stakeholders are also still unclear on what level of demand they should anticipate for the shots, though Freeman said member departments within her organization have been receiving increasing rates of phone calls about obtaining a vaccine since the CDC approved them.

HHS has not disclosed how many vaccines will be made available through the Bridge program, and Becerra did not provide a figure when asked directly about quantity on Wednesday.

“This is a billion-plus dollar program. As I said, you don't have to pay out of pocket for your vaccine but it is not … it's not cost-free. There are costs to making a vaccine available,” he said.

The secretary said the CDC will be paying a similar price per vaccine dose as it did in the past. The federal government previously paid roughly $20 per dose for the first round of coronavirus immunizations. The updated vaccines from Pfizer and Moderna are priced at $120 and $129, respectively, on the commercial market. 

Many health departments may not be able to cover the costs of these newer formulations, according to Freeman, even with reimbursements.

“Some of the challenges we're seeing specifically with the local health departments’ involvement are that there are some billing issues with the vaccine in that the reimbursement available to local health departments is less than the cost of the vaccine,” Freeman said. 

She noted one reimbursement rate she has been told of is $65 for every $120 dose.

Freeman added not all the doses allocated for the Bridge program will be immediately available, so health departments in areas with high rates of uninsured individuals may contend with low supply as manufacturers and distributors get the medicine out.

Still, Becerra projected confidence in vaccine access, saying that these early hiccups will be overcome soon.

“We've been working with the insurers for months and the pharmacist for months. We had to reach contracts with the various stakeholders. So, everyone's known but sometimes whether it's a computer glitch or maybe something else, something can get in the way,” said Becerra. “My sense is that these are glitches that will be addressed pretty quickly.”

Vance held a press conference Wednesday on his proposed legislation.

The bill would ban any federal official, including the president, from issuing mask mandates for domestic air travel, public transit systems or schools.

"We introduced this legislation to stop the federal government from reimposing mask mandates in part because I see this gnawing hysteria starting creep back into the country," Vance said.

As of now, there hasn't been any sign that anyone in federal or state leadership is considering mask requirements or widespread restrictions regarding COVID-19.

The Department of Health and Human Services says orders can be placed at COVIDTests.gov starting Sept. 25, and that no-cost tests will be delivered for free by the United States Postal Service.

Twelve manufacturers that employ hundreds of people in seven states have been awarded funding and will produce 200 million over-the-counter tests to replenish federal stockpiles for government use, in addition to producing enough tests to meet demand for tests ordered online, the department said. Federal officials said that will help guard against supply chain issues that sparked some shortages of at-home COVID tests made overseas during past surges in coronavirus cases.

Dawn O’Connell, assistant secretary for preparedness and response at HHS, said the website will remain functional to receive orders through the holidays and “we reserve the right to keep it open even longer if we're starting to see an increase in cases.”

“If there is a demand for these tests, we want to make sure that they're made available to the American people for free in this way,” O'Connell said. “But, at this point, our focus is getting through the holidays and making sure folks can take a test if they're going to see Grandma for Thanksgiving."

The tests are designed to detect COVID variants currently circulating, and are intended for use by the end of the year. But they will include instructions on how to verify extended expiration dates, the department said.

The initiative follows four previous rounds where federal officials and the U.S. Postal Service provided more than 755 million tests for free to homes nationwide.

It is also meant to complement ongoing federal efforts to provide free COVID tests to long-term care facilities, schools, low-income senior housing, uninsured individuals and underserved communities which are already distributing 4 million per week and have distributed 500 million tests to date, the department said.

O’Connell said manufacturers would be able to spread out the 200 million tests they will produce for federal use over 18 months. That means that, as demand for home tests rises via the website or at U.S. retailers when COVID cases increase around the country, producers can focus on meeting those orders — but that they will then have an additional outlet for the tests they produce during period when demand declines.

“We’ve seen every winter, as people move indoors into heated spaces, away from the outside that, over each of the seasons that COVID’s been a concern, that we have seen cases go up," O'Connell said.

She added that also “there’s always an opportunity or chance for another variant to come” but “we’re not anticipating that.”

“That’s not why we’re doing this,” O'Connell said. "We’re doing this for the fall and winter season ahead and the potential for an increase in cases as a result.”

HHS Secretary Xavier Becerra said that the "Biden-Harris Administration, in partnership with domestic manufacturers, has made great strides in addressing vulnerabilities in the U.S. supply chain by reducing our reliance on overseas manufacturing.”

“These critical investments will strengthen our nation’s production levels of domestic at-home COVID-19 rapid tests and help mitigate the spread of the virus," Becerra said in a statement.

The governor's diagnosis came hours after he attended a public press conference alongside Columbus Mayor Andrew Ginther for a new gun violence initiative. DeWine's office said he started experiencing "mild cold symptoms yesterday."

"Believing he had a mild head cold, he proceeded with his work day today," the governor's office wrote in a statement. "As the day progressed, his symptoms worsened, and his doctor advised that he take a COVID-19 test, which was positive. He reported having a 101-degree fever at the time of taking the test late this afternoon."

DeWine was resting at home as of Tuesday evening. The Ohio Department of Health said that the latest strain of COVID-19 can present like a head cold, and advised anyone experiencing even minor symptoms should take a test.

This is the second time that the 76-year-old governor has contracted the virus. He previously tested positive in August 2020, as part of a standard screening ahead of greeting then-President Donald Trump at Burke Lakefront Airport in Cleveland. He spent the next 14 days quarantining and was surprised to have contracted it, given the limited number of people he had been around.

The new shots from Moderna and Pfizer-BioNTech will hit the market just as the U.S approaches the fall and winter respiratory virus season. They arrive along with new treatments to protect infants and older adults from respiratory syncytial virus (RSV).

Here's what to know:

The vaccine protects against current variants

Like all the other COVID-19 vaccines, the updated version is not designed to prevent infection completely but is meant to reduce the severity of symptoms and curb the risk of "long COVID."

The updated shots were designed to target the XBB.1.5 variant, which was dominant when vaccine makers began to formulate and test a new version. 

That variant is no longer dominant and only accounts for about 3 percent of cases. But experts and administration officials have said the vaccines should still be effective at preventing severe infection against other variants that are circulating. 

A CDC expert said Tuesday that every variant circulating at any significant level is from the XBB lineage. That includes EG.5, the most prevalent variant, responsible for more than 21 percent of U.S. cases, according to the CDC. 

Recently, vaccine manufacturers have also said the shots provide protection against the BA.2.86 “Pirola” subvariant. There was some concern that Pirola might cause more infections because it's highly mutated, but new studies have shown this is not the case.

The shots will be available at major pharmacies 

Both CVS and Walgreens will have vaccines available in the coming days, following the CDC endorsement.

"Eligible individuals can schedule appointments immediately following CDC recommendation, with available appointments starting nationwide on Monday, September 18," Walgreens's Chief Medical Officer Kevin Ban said in a statement, adding that "earlier appointments may be added on a rolling basis as stores receive vaccines this week."

A spokeswoman for CVS said doses should be arriving this week. 

The demand is unclear

Just because the vaccine was recommended for every American doesn't mean that people will be rushing out to get it.

In the past year, only about 20 percent of adults received the bivalent booster shot, and experts have said they don't expect much difference with the newest version.

COVID-19 cases and hospitalizations are steadily rising, but the numbers are far below where they were at the height of the pandemic; infections are not surging, and hospitals are far from being overwhelmed like they were at the height of the pandemic.

More than 95 percent of the U.S. population already has some level of COVID immunity, whether it’s from vaccination, infection or both. 

However, vaccines are most effective in people who are older and with weaker immune systems because of underlying conditions. According to a CDC presentation Tuesday, most people who had been hospitalized since January 2023 did not receive a bivalent booster.

Some people may have to pay

This is the first time the federal government isn't buying and distributing the shots, because the public health emergency expired in May. The COVID vaccine is now commercialized, just like the flu shot and other vaccines.

That puts the burden of ordering shots on hospitals, physician offices and pharmacies, and on the public for paying for it. 

The CDC's recommendation followed the endorsement of its expert advisory panel, which should make the vaccines free for most consumers who have private and government-sponsored insurance.

There could be barriers for the estimated 25 million to 30 million people without insurance. Without discounts, Pfizer said its shot will cost $120 per dose, Moderna said it will charge $129 per dose, and Novavax will charge $130 per dose. 

Uninsured or underinsured Americans will have access to free shots as part of the Biden administration’s “Bridge to Access” program, which will keep a limited supply of vaccines and therapeutics on hand to distribute free through state and local health departments, as well as pharmacies. The program is meant to be temporary, and will expire in December 2024.

The Department of Health and Human Services said vaccines will be available under the program as early as this week rather than October, as was initially forecast.  

Vaccines likely will be updated annually 

The Biden administration is refraining from calling the updated shots a booster, likely reflecting a concern that much of the public is vaccine-fatigued and has moved on from pandemic worries. Instead, it is being marketed as an annual shot, just like the flu vaccine.

People who are immunocompromised may receive an additional dose at least two months after getting the new shot.

“Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine,” the Food and Drug Administration said Monday.

Dr. Mandy Cohen said, "We're in our strongest position yet to fight COVID-19."

"The federal government is putting vast amount of money into research and these MRNA vaccinations are really, really working," said John Giramendi, a Democrat from California.

Last week, though, Sen. Rand Paul of Kentucky criticized the recommendation of multiple doses for kids.

"Norway, South America and the UK all chose to recommend only one dose of Pfizer due to the risk of cardio vascular side effects for boostering kids," Paul said.

But Dr. Anthony Fauci said it's important to consider all the facts. "The risk of myocarditis from COVID itself is greater than the risk of the vaccine."

Virginia Sen. Tim Kaine said research and COVID vaccine development need to go further.

"I'm wondering," the Democrat said, "whether there are alternative vaccines that can be developed that could be more durable."

Kaine also wants to the federal government to do more research on long COVID "and also to spread best practices to providers and employers and patients."

Last year, Kaine helped secure $10 million in funding for long COVID research and he's hoping for an additional $10 million in the new budget.

The CDC panel's decision comes a day after the Food and Drug Administration also chose to recommend the new formulation. However, there is one more key step that needs to happen before the vaccines can be administered.

CDC Director Dr. Mandy Cohen still needs to give the green light, which could happen as soon as Tuesday evening, NBC News reported.

Once that happens, the updated vaccines will be available at local pharmacies and vaccination sites as soon as 48 hours, according to CNN. One Pfizer official said his company expected to have doses available at some U.S. locations as early as Wednesday.

Both Moderna and Pfizer have updated their vaccine formula to focus on the omicron strain of the virus, whose many subvariants have been dominant in the U.S. since December 2021.

Another vaccine manufacturer, NovaVax, also has an updated option it has created, but it's still under review by the FDA.

The new vaccines will be available at pharmacies, health centers and some doctor's offices. Locations will be listed on the government's vaccines.gov website. You should be able to get the new dose and a flu shot at the same time.

The CDC panel's vote was 13 to 1 in favor of recommending the updated booster, CNN reported.

The Associated Press contributed to this report.

Outside advisers for the Centers for Disease Control and Prevention (CDC) on Tuesday will recommend who should get the shots, which are manufactured by Moderna and Pfizer-BioNTech.

Once CDC Director Mandy Cohen signs off, the shots will be available to the public. 

An application for an updated vaccine from Novavax, the only non-mRNA vaccine, is still pending. The FDA referred questions to the company.

“Novavax is currently responding to the FDA’s requests to facilitate final review, and timing is ultimately at the discretion of the FDA,” the company said in a statement Monday, adding that doses of its vaccine have arrived in the U.S. for distribution, should they receive regulatory clearances.

The updated COVID-19 shots will hit the market just as the U.S approaches the fall and winter respiratory virus season. They arrive along with new treatments to protect infants and older adults from respiratory syncytial virus (RSV).

"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We very much encourage those who are eligible to consider getting vaccinated.”

The updated shots were designed to target the XBB.1.5 variant, which was dominant when vaccine makers began to formulate and test a new version. That variant is no longer dominant, though experts and administration officials have said the vaccines should still be effective at preventing severe infection against other variants that are circulating, because they're closely related.

It's not yet clear what populations the shots will be considered for. Last year, the CDC's advisory panel recommended only older and at-risk populations get the omicron-specific booster, but the agency decided instead to recommend everyone get the shots.

That recommendation "diluted the message" of who would most benefit from the shots, said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

COVID-19 cases are rising, but the numbers are far below where they were at the height of the pandemic. Infections are not surging, and hospitals are far from being overwhelmed like they were at the height of the pandemic.

More than 95 percent of the U.S. population already has some level of COVID immunity, whether it's from vaccination, infection or both. The new vaccine should provide the best protection for a few months before starting to wane, and will likely have the biggest impact on people who are older with underlying conditions, as well as some people who are immunocompromised.   

The risks of serious illness for healthy younger people are low, though any infection carries a risk of turning into "long COVID," when symptoms linger for months or even years. 

"It's also important for people to realize that high-level protection from the vaccine lasts on the order of three to four months, and it's less clear what persists after that," said Jesse Goodman, an infectious disease specialist and professor of medicine at Georgetown University.  

"I think certainly, for the people at risk, it's a clear-cut advantage to get immunized, but for others, it's a risk benefit decision," Goodman said.

The Biden administration is refraining from calling the updated shots a booster, likely reflecting a concern that much of the public is vaccine-fatigued and has moved on from pandemic worries. Instead, it is being marketed as an annual shot, just like the flu vaccine.

"Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine," the FDA said Monday.

That messaging is also being echoed by the manufacturers.

"We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time," said Stéphane Bancel, Moderna CEO.

More than a year after the omicron boosters were rolled out, only about 17 percent of the public received a shot, and only about 43 percent of people over age 65.

The rollout of the newest shots is also complicated by the fact that they are no longer bought and distributed by the federal government, because the public health emergency expired in May. 

That puts the burden of ordering shots on hospitals, physician offices and pharmacies, and on the public for paying for it. 

Pfizer and Moderna have decided to charge up to $130 a shot, compared with $30 last year for the booster, which was produced under government contract.

People who have Medicare or private insurance likely won't face any out-of-pocket costs, unless they see a provider who is out of network. 

Uninsured or underinsured Americans will have access to free shots as part of the Biden administration’s “Bridge to Access” program, which will keep a limited supply of vaccines and therapeutics on hand to distribute free through state and local health departments, as well as pharmacies. But they may not be available at pharmacies until mid-October at the earliest.

Some experts said they are worried a lot of people may fall through the cracks in the system; just because the vaccine may be available doesn't mean getting it to people will be easy. The uninsured may not know how to get the vaccine, or even that it's available.

"I think that there's going to be vaccine available, but it's not going to be what people saw before, because there's going to be more and more hoops to jump through," said Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. 

"And that's going to make it more complex, which then gets back to how clear the messaging is for people [about] what they're supposed to do and what they're supposed to expect when they go to the same place they went before, but it's not the same drill," Gellin said. 

A Moderna spokesman said the company is working with the government on the "Bridge" program, but did not provide more details. 

Some people without insurance may be able to get boosters free from safety net providers, but others may have to pay the full cost. 

Updated at 4:05 p.m. ET

The Federal Drug Administration is expected to approve the updated shots as early as Friday, according to NBC News. That would pave the way for the Centers for Disease Control and Prevention to give final approval next week. The CDC's panel of independent advisers is set to meet Tuesday, WABC-TV reported.

COVID-19 hospitalizations and deaths are rising by double-digit percentages, according to CDC data, though rates remain far below pandemic-era levels.

Here's what you need to know about the updated shot:

When will it be available?

Potentially, as soon as Sept. 13.

First, the FDA will meet — possibly this week — to approve the shot. After it does, a panel of independent advisers to the CDC will meet and recommend who should be eligible for the shots. The panel is set to meet on Tuesday.

After the panel finalizes its recommendation, the CDC director will give the final signoff, which typically comes soon after.

What's new about this booster?

The latest shot will target the XBB.1.5 omicron subvariant. While CDC data shows it's no longer the dominant strain, the updated booster should protect against other current subvariants, NBC News reported, citing drugmakers and experts. EG.5 is the current dominant strain.

Moderna claims its new vaccine is effective against the newly emerged B.2.86 variant, unofficially dubbed “Pirola,” which the CDC has warned may be more infectious than other strains among those who have had COVID before.

“Taken together with our previously communicated results showing a similarly effective response against EG.5 and FL.1.5.1 variants, these data confirm that our updated COVID-19 vaccine will continue to be an important tool for protection as we head into the fall vaccination season,” Moderna President Stephen Hoge said in a statement.

Who should get the shot?

That remains to be seen. The FDA and CDC will make that determination at their meetings over the next week.

However, the CDC already recommends that everyone receive an updated COVID-19 vaccine, in addition to the original 2021 shots, and that people older than 65 receive a second booster on top of that.

If you recently had COVID, the CDC recommends delaying a booster shot for three months after symptoms started, or if asymptomatic, after a positive test.

Will it be free?

For the first time, the federal government will not cover the cost of the booster.

Both Moderna and Pfizer have said they plan to offer the shots for around $110 to $130 on the commercial market. Those with Medicare or private health insurance will likely continue to pay nothing at all, or very little, according to the Kaiser Family Foundation.

For those who have no insurance or are underinsured, the Biden administration has set up a "bridge program" that will offer access to free boosters through December 2024. The vaccines will be available at select health care providers, community health centers and pharmacies.

Can I get a flu shot at the same time?

Yes. In fact, public health officials are urging the public to prepare to head off what some worry could be a “tripledemic.”

About two-thirds of Americans plan to get the annual flu shot, according to pharmacy chain CVS.

Similar to the treatments for COVID-19, RSV — or respiratory syncytial virus — can be treated with monoclonal antibodies, which the CDC expects to be ready by early October.

The Hill and NewsNation affiliate KTLA-TV contributed to this report.

Hospitalizations and deaths are rising by double-digit percentages, according to Centers for Disease Control (CDC) data, though rates remain far below pandemic-era levels.

The change in season also means cooling temperatures, cold season and the return of children to schools around the country — all of which could exacerbate current trends.

Here's what to know about the current state of COVID-19.

Hospitalizations, deaths on the rise

COVID-related hospitalizations rose by 16 percent from mid to late August, according to the most recent CDC data available. That continues a trend that started in July after record-low hospitalization rates this summer.

Cases could be rising faster, experts believe, with many cases going unreported and an end of pandemic-era data collection.

“Everything is much more gray and hazy now because we no longer have a good sense of how many cases are occurring right now in the U.S.,” said Andrew Pekosz, a professor of immunology at the Johns Hopkins Bloomberg School of Public Health.

“It's difficult to put those hospitalization and death numbers in context. Are we seeing a 10 percent increase in hospitalizations but a 100 percent increase in cases? That's where it becomes really sort of difficult to make those population estimates.”

“The numbers are much higher than we think they are,” he said.

Deaths from COVID are also going up, about 18 percent in the same period of August, according to CDC data. Over half of the country saw “substantial” increases in COVID-19 in August, with 26 states seeing hospitalizations rise by more than 20 percent, according to the CDC.

While COVID appears to be more common now, Pekosz said, some of the anecdotal sicknesses may be normal respiratory diseases.

“I think there is something to be said about rising [COVID] rates. I think it's also important to note that there are other things that cause respiratory infections that go around,” he said.

“That's where the testing becomes so important because it really allows you to cut through and understand what COVID is contributing to this, versus what are other infections that are normally starting to rise around this time of the year contributing to overall health.”

Vaccine booster coming soon as new variant appears

The major COVID vaccine manufacturers — Moderna, Pfizer and Novavax — are all slated to roll out another vaccine in the coming weeks, pending final approval from the Food and Drug Administration, which could come this week.

That new vaccine is based on the XBB.1.5 variant of COVID, a subvariant offshoot of the Omicron variant which caused massive caseloads late last year.

The CDC already recommends everyone receive an updated COVID-19 vaccine, in addition to the original 2021 shots, and people older than 65 receive a second booster on top of that.

Pekosz recommends everybody get the new COVID vaccine when it becomes available in a few weeks.

Slightly less than half of the country has received updated COVID vaccines, according to CDC data, and even fewer have received additional shots if they are eligible. States in the south tend to have lower updated vaccine rates.

Texas has the lowest rate of people fully up to date on shots, with just 3.3 percent of people receiving all vaccines as of the end of July. Vermont leads the country with 37 percent.

Moderna claims its new vaccine is effective against the newly-emerged B.2.86 variant, unofficially dubbed “Pirola,” which the CDC has warned may be more infectious than other strains among those who have had COVID before.

Pirola currently accounts for less than 1 percent of COVID cases in the U.S., according to the CDC, but has worried experts due to its over 30 mutations from previous versions of the virus.

Are masks coming back?

The rising caseload has reignited debate over whether people should wear masks to protect themselves and others from the spread of COVID-19.

While government mask mandates are not on the table, former White House medical adviser Anthony Fauci said recommendations to wear masks in public could return soon if trends continue to worsen.

“I am concerned that people will not abide by recommendations,” he said in a CNN interview last week. “I would hope that if we get to the point that the volume of cases is such and organizations like the CDC recommends — CDC does not mandate anything — recommends that people wear masks, I would hope that people abide by that recommendation and take into account the risks to themselves and their families.”

Pekosz said that certain businesses and other places could very well see mask requirements return, specifically nursing homes and hospitals.

“Masks work when they're worn effectively,” he said. “High quality masks, in particular, is something that I think is important for everyone to consider.”

New York Gov. Kathy Hochul announced the state will make free masks and COVID-19 tests available to students as the school year starts this week, in possible anticipation of rising cases.

“Frequent testing for COVID-19 is an important part of keeping our kids safe and preventing an outbreak, and I will continue working to ensure our school districts have the resources they need to provide a safe, in-person learning environment for our students,” Hochul said in a Wednesday statement.

The White House has said President Biden will increase his mask-wearing after first lady Jill Biden was diagnosed with COVID this week. The president has tested negative thus far.

Other protective measures

Common precautions since the start of the pandemic — properly washing hands, wearing masks, avoiding especially crowded areas — still apply three years later, experts say.

“It's a great time to be reminded of ‘COVID protocol,’ for lack of a better word,” Pekosz said.

Common early symptoms of COVID include a fever, a cough, fatigue, headaches and chills. 

While free test programs from the federal and local governments have concluded, you can pick up a quick at-home test from your local pharmacy for about $20. COVID tests also expire, so ensure your supply is up to date, Pekosz said.

It’s also recommended to stay home if you have any respiratory sickness, COVID or not, to keep the community safe.

Will there be another wave?

While a new wave of COVID sweeping the country is certainly possible, Pekosz said anything comparable to the Omicron wave last year is unlikely.

“We have to understand that COVID is here, and COVID is staying here,” he said. “I expect that we'll see increases in cases. But I don't expect to see something that was similar to what we saw across the population where we saw massive increases of cases over a short period of time.” 

“So we'll see increases, particularly viruses tend to circulate in schools quite effectively. But I don't see anything concerning with respect to massive surge,” he added.

But Pekosz noted there is a rising risk as summer ends and indoor gatherings become more common.

“It's important to note that we're starting with a baseline of cases that's pretty high, and now we're seeing a surge in the fall and people are getting into environments where the virus is much more transmissible,” he said.

Massive bird migration caught on radar

The Freedom to Breathe Act would prevent the reimposition of mask mandates in the United States and would apply through the end of 2024. It would prevent the president or any other federal official from mandating masks at airports, schools, universities, public transit and other public institutions.

“We tried mask mandates once in this country. They failed to control the spread of respiratory viruses, violated basic bodily freedom, and set our fellow citizens against one another," Vance said. "This legislation will ensure that no federal bureaucracy, no commercial airline, and no public school can impose the misguided policies of the past. Democrats say they’re not going to bring back mask mandates – we’re going to hold them to their word.”

Vance said the legislation is needed after some universities and businesses have started to impose mask mandates. Last month, Hollywood studio Lionsgate announced it is returning to mask mandates for many of its employees amid rising COVID-19 cases reported in Los Angeles.

Vance said he plans to officially introduce the legislation later on Tuesday.

Surges of COVID-19 cases in Texas and Kentucky have caused three school districts to briefly suspend in-person classes.

But few schools have taken those steps so far, and superintendents contend that without national guidance, it is highly unlikely we’ll see a return of mass closures or mask mandates. 

In the post-emergency era of COVID-19, schools no longer have the comprehensive surveillance data that was readily available during the pandemic, though some local data remains available to inform their decision-making.

And without specific guidance, decisions on COVID mitigation measures are largely up to school district leaders, in cooperation with local health authorities and in consultation with the community.

“Superintendents will not make these calls in isolation,” said George Roberts, a Maryland superintendent. “What they did do during COVID, and what they're currently doing now — and I suspect will continue to do as we get into the fall and winter season — is work in conjunction with their own internal health office” in their county or city. 

A common refrain from health experts with the end of the pandemic is that people should use viral mitigation methods based on their own degree of risk tolerance. With government actions unlikely to occur now, the same can be said for schools.

“Schools need to have a latitude to help protect their staff and their students,” said Sterling Ransone, family physician and board chair of the American Academy of Family Physicians.

“They can contact their health department, they can contact their family physicians and they can respond more rapidly to potential emerging respiratory diseases that are in their community,” Ransone said.

In the current situation, schools are focusing on the COVID-19 mitigation tactics they’ve had in place since mask mandates dropped, such as emphasizing hygiene and making sure anyone who contracted COVID-19 stays home for at least five days. 

Ransone lamented that school administrators may find themselves in a “can’t win” position this year as they precariously balance the health needs of their students and staff with politicized blowback if they do take concerted action against viral spread.

School closures and mask mandates became an explosive issue in school board meetings and have been the topic of multiple congressional hearings as student learning plummeted during the pandemic. 

The last test scores released by the National Assessment of Educational Progress (NAEP) in June showed average scores for 13-year-olds in mathematics are their lowest point since 1990, and reading shot down to levels seen in 2004.

PJ Caposey, superintendent of Meridian School District in Illinois, said he is “terrified” of the prospect of discussions to implement mask mandates or school closures again. 

"I’m terrified of what may happen and that people, on either end of the political spectrum, wouldn't respond to data and information and respond to their political ideology," Caposey said.

Despite the difficulties that can come with making the decisions, most superintendents likely prefer having local control. 

“I would definitely think people are happy they have the autonomy to make that decision, absolutely,” said Ronnie Harvey Jr., an administrative director of special education at a school district in Louisiana. 

Harvey compared the public health approach to how schools cater instruction to the learning needs of different students. 

“I think when you do the blanket approach, it is just like when we deliver instruction from a district personnel. When we push out some type of mandate for the district, we do focus on individualized instruction,” he said. 

The majority of school districts in the U.S. have already started the academic year, meaning students are returning to classrooms without yet having the protection offered by the bevy of new preventive treatments.

Young children this year can benefit from preventives against RSV, a common daycare disease that surged in children last year. The antibody for infants and toddlers is expected to roll out in time for this year’s RSV season, which typically starts in the fall and peaks during winter.

The updated COVID-19 vaccines are anticipated to become available by the end of September, less than ideal when cases and hospitalizations are on the rise.

Those in the health care sphere had hoped these products could have been made available sooner but also acknowledge the need for a proper review to be conducted before sending them onto the market.

The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices is scheduled to hold a meeting on the COVID-19 vaccines Sept. 12. Vaccine manufacturers have said they are prepared to roll out shots as soon as approval is granted.

When the federal public health emergency ended, reporting requirements on case rates went away as well. Much of what can be gleaned on viral spread is dependent on hospital admissions and wastewater detection. The current data hints at viral spread potentially becoming worse.

Hospital admissions rates have been rising since July, though deaths have not risen to the same degree, and early data suggests they may have even declined in recent weeks. Without case data, community COVID levels and their related recommendations are based on hospital admissions.

A few weeks ago, there were no U.S. counties with high COVID-19 hospital admission rates — meaning more than 20 admissions per 100,000 people. There are now seven in Texas and along the border of Mississippi and Alabama. 

The vast majority of the country — 96.15 percent — still has low admissions rates, according to CDC data. The number of counties with high admissions account for less than half of 1 percent of counties.

And though a few districts have reacted similarly to how schools responded to COVID in 2020, the U.S. is far more equipped now than it was then. Testing and antivirals are readily available. Updated vaccines are on the way, and almost everyone has some degree of antibody protection from prior infection or immunization.

“I always have concern, but I would just say that, overall, I know that my concern level as of today ... is no different than it's been at any point in the last 15 months,” Caposey said.

COLUMBUS, Ohio (WJW) -- A new and highly mutated coronavirus variant being watched by health officials has been confirmed in one case in Lorain County, the Ohio Department of Health announced on Thursday.

There have been 23 other COVID-19 cases caused by the BA.2.86 variant worldwide, including one case in Michigan and another in Virginia, according to a Thursday news release.

The new variant was first detected earlier this month in samples from Denmark and Israel, according to the U.S. Centers for Disease Control and Prevention.

It contains a number of mutations that set it apart from other coronavirus lineages and may be better at infecting persons who have had COVID-19 or been vaccinated against it, according to the CDC.

"At this point, there is no evidence that this variant is causing any more severe illness, hospitalizations or deaths," Dr. Bruce Vanderhoff, director of the state health department, is quoted in the release.

For the two weeks ending Aug. 12, four coronavirus variants of concern were responsible for about half of all the coronavirus infections in the state, according to the Ohio Department of Health's COVID-19 variant dashboard: three from the omicron XBB lineage; and the fourth was the omicron EG.5 variant.