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The Food and Drug Administration on Thursday approved the latest slate of annual Covid vaccines, clearing the way for Americans 6 months and older to receive updated shots in the midst of a prolonged summer surge of the virus.
Pfizer and Moderna, the vaccine makers, are expected to begin shipping vaccines to pharmacies and doctors offices within days. The shots are tailored to a version of the virus that took off this spring before giving way to closely related variants, all of which appear to spread faster.
For the frailest Americans, who have been dying of Covid in growing numbers this summer, the shots could offer a reprieve from a virus that disproportionately endangers those whose vaccinations are out of date.
But the approval is occurring months after wily new variants began driving up infections, a matter of consternation for some scientists who have urged faster turnarounds for updated shots.
In recent weeks, people have been hospitalized with Covid at a rate nearly twice as high as during the same time last summer. By late July, Covid was killing roughly 600 Americans each week, a substantial drop from this winter but double the number from this spring.
The availability of boosters has not translated into actual vaccinations. By spring, only one in five adults had received last years updated Covid vaccine. Even older Americans, who are at far greater risk of being severely sickened, largely spurned the shots, with only 40 percent of people 75 and older taking last years vaccine.
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Pfizer COVID-19 vaccine.
Courtesy: Pfizer
The Food and Drug Administration on Thursday approved updated Covid vaccines from Pfizer and Moderna, putting the new shots on track to reach most Americans in the coming days amid a summer surge of the virus.
The jabs target a strain called KP.2, a descendant of the highly contagious omicron subvariant JN.1 that began circulating widely in the U.S. earlier this year. KP.2 was the dominant Covid strain in May, but now only accounts for roughly 3% of all U.S. cases as of Saturday, according to the latest Centers for Disease Control and Prevention data.
Still, Pfizer and Moderna have said their KP.2 vaccines can produce stronger immune responses against other circulating subvariants of JN.1, such as KP.3 and LB.1, than last year's round of shots targeting the omicron strain XBB.1.5 can.
"Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
In June, the CDC recommended that everyone over 6 months old receive an updated Covid vaccine and flu jab this year. The new shots from Pfizer and Moderna are specifically approved for people ages 12 and older and are authorized under emergency use for children 6 months through 11 years old.
Pfizer will begin shipping its new shot immediately and expects it to be available in pharmacies, hospitals and clinics across the U.S. "beginning in the coming days," the company said in a statement.Moderna also expectsitsshotto be available in a similar time frame, according to a statement.
"Staying up to date with your COVID-19 vaccine remains one of the best ways for people to be protected and prevent severe illness," Moderna CEO Stephane Bancel said in a statement. "We appreciate the U.S. FDA's timely review and encourage individuals to speak to their healthcare providers about receiving their updated COVID-19 vaccine alongside their flu shot this fall."
Moderna Covid-19 Vaccine mRNA 2024-2025 formula.
Courtesy: Moderna
The FDA's approval comes a few weeks ahead of last year's round of shots, which the agency cleared on Sept. 11.
The earlier arrival of updated vaccines could offer some reassurance to Americans as the nation sees a relatively large spike in the virus this summer. A "high" or "very high" level of Covid is being detected in wastewater in almost every state, according to CDC data. Wastewater monitoring provides a glimpse of how widespread the virus is in the U.S. as other forms of testing have fallen off.
Other measures of the virus are rising but remain far below where they were at the peak of the pandemic. Covid test positivity rates rose to 18.3% for the week ended Aug. 10, from 17.9% the week before, according to the CDC.
Meanwhile, the CDC said about four people are being hospitalized for Covid for every 100,000 people in a given area. That's up from about one Covid hospitalization for every 100,000 people in May, which was the lowest level since the pandemic began.
The summer Covid wave may decline by the time the shots reach patients' arms and kick in an immune response against the virus, which typically takes two weeks after vaccination.
Still, federal health officials have long told Americans to expect annual updates to Covid shots as the virus churns out new strains that can dodge the immunity people have from previous vaccinations or infections protection that wanes over time. It's similar to how the U.S. rolls out new flu vaccines every year.
It's unclear how many Americans will actually roll up their sleeves to get another shot in the coming months.
Only around 22.5% of U.S. adults received the latest round of shots that came out last fall, according to CDC data through early May.
Many Americans who got previous rounds of Covid shots cited a lack of worry about the virus as a reason they didn't get the latest booster, according to a November survey from health policy research organization KFF. Others said they had been too busy to get their shot, the survey said.
In June, the FDA asked vaccine makers to manufacture shots against JN.1 before telling them to target KP.2 instead "if feasible."
That shift appeared to put Novavax, which filed for authorization of a new JN.1 shot that same month, at a disadvantage. The FDA has not cleared the biotech company's jab.
In a statement, Novavax said it is working "productively" with the FDA as the agency completes its review. Novavax expects its shot to receive authorization in time for peak vaccination season in the U.S.
The company noted that its shot provides protection against descendants of JN.1, including KP.2.3, KP.3, KP.3.1.1 and LB.1.
Novavax manufactures protein-based vaccines, which cannot be quickly updated to target another strain of the virus. Protein-based technology is a decades-old method used in routine vaccinations against hepatitis B and shingles.
Meanwhile, Pfizer's and Moderna's shots use messenger RNA technology, which teaches cells how to make proteins that trigger an immune response against Covid. The mRNA vaccines are much easier to develop and update than protein shots.
BALTIMORE -- On Thursday the FDA approved updated COVID-19 booster shots from Moderna and Pfizer that would target the KP.2 strain of the coronavirus. Officials say KP.2 has spread rapidly these past few months, highlighting the warning as we head into fall and its respiratory hotbed.
"The virus is changing but also the infections that we get from past infections or past vaccines, wanes over time," Dr. Mandy Cohen, Director of the Center for Disease Control and Prevention said.
"Last fall and winter, 10% of the U.S. population had the flu at the peak of the respiratory illness season, more than 2500 people a week were dying from COVID-19," Jeff Nesbit, Assistant Secretary for Public Affairs at the U.S. Health & Human Services said.
Health officials especially want older Marylanders and those who are immunocompromised to make sure they get the updated annual booster, the flu shot, and the RSV vaccine to avoid a trip to the emergency room.
"We're talking about a vaccine that is continuing to evolve and it is likely that what's going to be there four or five months from now, will further evolve from where it is now," Dr. Peter Marks of the Food and Drug Administration said.
"So, you want to make sure you're getting the highest level of protection you possibly can going into [the] season where we know we will see more of the COVID virus circulating, the flu virus circulating," Cohen said.
Now that the updated booster has been approved, Moderna and Pfizer have already started shipping the latest vaccine. Officials are encouraging those most vulnerable to get it as soon as possible, while others can wait until October to maximize protection.
However, their message is to just get it done to protect yourself and others.
"Even though COVID is not the flu, being able to get that shot in the arm is what we really need to have happen, that's the point of this campaign here," Marks explained.
The Biden Administration announced that starting in late September four free COVID tests will be mailed to Americans, a one-two punch to keep people safe as we head into respiratory illness season.
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Fiona Moore / Flickr cc
Closely following theMediterranean Diet may help protect against COVID-19, but its benefits against symptoms or severity are unclear, Indonesian researchers report in PLOS One.
Thesystematic review, conducted in August 2023, identified six observational studies from five countries published from 2020 to 2023 that were based on food-frequency questionnaires. They had a total sample size of 55,489 patients.
The Mediterranean Diet, which mainly consists of plant-derived foods such as fruits, vegetables, legumes, nuts, and olive oil, is a rich source of antioxidants and is tied to a lower risk of infection and faster viral clearance, the authors said.
"Mediterranean Diet has been reported to possess immunomodulatory and anti-inflammatory properties," they wrote. "These properties are closely associated with the immunopathogenesis of COVID-19."
Four of the six studies identified a statistically significant correlation between closer adherence to the Mediterranean Diet and lower COVID-19 infection risk, while one study found a nonsignificant link.
One study reported a significant tie between better adherence to the diet and reduced COVID-19 symptoms, but three showed a nonsignificant association. While one study found that highly adherent participants were less likely to develop severe COVID-19, two others were inconclusive.
Overall, the analyses suggest higher Mediterranean diet adherence significantly reduced odds of COVID-19, with non-significant results against COVID-19 symptoms and severity.
One study concluded that dietary adherence significantly reduced the likelihood of all reported COVID-19 symptoms, with odds ratios (ORs) varying from 0.06 to 0.34 for each symptom. But three found a nonsignificant association (ORs, 0.84 to 0.992), and one analysis concluded that the link was nonsignificant.
One report found that participants with top-tertile dietary adherence were less likely to develop severe COVID-19 (OR, 0.23) than those in the bottom tertile. Two studies reported a nonsignificant link (ORs, 0.22 to 0.89).
Of two studies that analyzed the effects of individual dietary components against disease severity, one found no significant link, while another reported that consumption of more vegetables, fruits, legumes, nuts, whole grains, and fish were protective.
"Overall, the analyses suggest higher Mediterranean diet adherence significantly reduced odds of COVID-19, with non-significant results against COVID-19 symptoms and severity," the researchers wrote.
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Though the United States may be past the peak of its latest COVID-19 surge, federal health officials are eying ways to reduce the spread of the virus over colder months and the holiday season, including a relaunch of free COVID tests by mail.
The announcement comes as health providers gear up immunization activities ahead of the main respiratory virus season. Officials from federal agencies shared their outlooks for the upcoming season, along with the status on the tools to prevent them, at a media briefing today.
Dawn O'Connell, JD, assistant secretary for preparedness and response at the Department of Health and Human Services, said that, starting in September, people can order four free COVID tests to be delivered through the mail.
This is the seventh round of free tests since 2021, and the mail delivery program, combined with year-round access at outlets such as community clinics, has so far delivered nearly 1.8 million tests.
They do no good sitting in medicine cabinets.
She urged people to order the tests as families move indoors as the weather cools and as people prepare for travel and the holidays. O'Connell also urged people to use them. "They do no good sitting in medicine cabinets."
CDC Director Mandy Cohen, MD, MPH, said the CDC's forecasting for the fall and winter suggests similar or lower numbers of peak hospitalizations for all three of the main respiratory illnesses: COVID, flu, and respiratory syncytial virus (RSV) infection.
She included a caveat, however, that assumptions could change, based on changes in SARS-CoV-2, the virus that causes COVID-19, which evolves faster than flu, and other factors.
At today's briefing, health officials fielded questions about COVID vaccine access to lower-income and uninsured people, as well as regarding who should be vaccinated, especially given the current level of high activity.
The federal government's bridge access program, launched last September to provide broad COVID vaccine access to millions of uninsured Americans, has now ended due to budget recissions. But at today's briefing, Cohen announced that the CDC has identified $62 million in funding for state and local health departments to obtain the vaccine.
She also added that free access to the antiviral drug Paxlovid through an assistance program run by Pfizer is available until the end of 2024 and that both Pfizer and Merck have assistance programs for uninsured and underinsured people.
When asked about the timing of updated vaccines, for which approval came yesterday for the two mRNA vaccines, Peter Marks, MD, who directs the Food and Drug Administration's Center for Biologics Evaluation and Research, said officials are always looking for concerning mutations and whether a vaccine update is urgently needed. However, he said the main consideration currently is getting doses into patient's arms, and that fall vaccination drives are the most realistic way to ensure that many people are vaccinated and boost their immunity to the virus.
The only way to get long COVID is having COVID.
Health officials said COVID is still more dangerous than flu, and Marks emphasized that the vaccine's impact against getting COVID is also a way to prevent long COVID. "The only way to get long COVID is having COVID," he said.
For respiratory viruses as a whole, activity is still low, but wastewater levels for COVID are still at the very high level, the CDC said today in its latest data updates. Levels are still highest in the West, which continues to show a declining trend. The South and Midwest are also showing downward trends.
The latest data from WastwaterSCAN, a national wastewater monitoring system based at Stanford University in partnership with Emory University, shows that SARS-CoV-2 detections remain high in all regions, but with a downward trend over the past 3 weeks nationally and in the Northeast, South, and West.
Meanwhile, test positivity for COVID was at 18% nationally, the same as the previous week, with the highest levels in Texas and surrounding states. Emergency department visits for COVID were down a bit, and deaths remained level.
The Centers for Disease Control and Prevention's COVID-19 data tracker shows an 18.1% test positivity rate for the week ending Aug. 10, the highest it has been since January 2022. Wastewater surveillance, an early warning sign of COVID-19s spread in communities, demonstrates very high viral activity for COVID-19 across the U.S. indicating positivity rates could be even higher than reported test results. CDC recommends that everyone ages six months and older receive a 2024-2025 COVID-19 vaccine.
In advance of the respiratory virus season, the Department of Health and Human Services Aug. 19 launched a new public education campaign on common respiratory viruses and available vaccines including flu, COVID-19 and respiratory syncytial virus (commonly known as RSV).
The updated mRNA vaccines target a strain called KP.2, which is circulating now and is expected to ramp up in the fall and winter months.
PORTLAND, Ore. On Thursday, the Food and Drug Administration (FDA) approved two new COVID-19 vaccines one from Moderna and one from Pfizer marking the third time the vaccines have been updated to keep up with new strains of the virus.
Leaders with the Oregon Health Authority (OHA) said the approval, which came earlier than last year, was not unexpected. The mRNA vaccines target a strain called KP.2, which is circulating now and is expected to ramp up in the fall and winter months. OHA couldn't give an exact timeline of when Oregonians would be able to get the updated vaccines, but did say they'd be available in the coming weeks.
"I think for people that are on the fence and say, 'Oh, a new FDA vaccine, I'm going to wait,' this is the same vaccine that we have been using for the past several years," said Dr. Dean Sidelinger, OHA's health officer and state epidemiologist. "It is updated to fight some of the more recent variants, but the technology, the proven science behind this vaccine, has been with us for several years."
Health officials stress the protection they'll offer, especially against severe disease.
"Certainly it's much safer and much less miserable to get a COVID vaccine than it is to have to recover from COVID to get that protection," Sidelinger said, "Because even those people who aren't in the hospital, if you recently have it, you know, have reported a lot of brain fog and really bad fatigue."
Sidelinger explained that those most at risk should get the shots sooner, including older adults, younger children and people who are immunocompromised.
"But all of us, you know, six months and older should consider getting this vaccine. The protection starts within weeks after getting the vaccine, so if you're someone who's at higher risk with COVID still circulating at fairly high levels, now it will offer you protection from the summer wave," Sidelinger said.
