Pfizer COVID-19 vaccine.
Courtesy of Pfizer
The Food and Drug Administration on Thursday approved updated Covid vaccines from Pfizer And Modernallowing the new vaccines to reach most Americans in the coming days amid a summer virus surge.
The shots target a strain called KP.2, a descendant of the highly contagious omicron subvariant JN.1 that was widespread in the U.S. earlier this year. KP.2 was the dominant Covid strain in May, but as of Saturday accounts for only about 3% of all U.S. cases, according to the latest data from the Centers for Disease Control and Prevention.
Still, Pfizer and Moderna have said their KP.2 vaccines can elicit stronger immune responses against other circulating subvariants of JN.1, such as KP.3 and LB.1, than last year's round of vaccinations against the omicron strain XBB.1.5..
“Given the waning population immunity from previous exposure to the virus and from prior vaccinations, we strongly recommend that eligible individuals get vaccinated with an updated COVID-19 vaccine to provide greater protection against the variants currently circulating,” said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement.
In June, the CDC recommended that everyone over 6 months of age get an updated Covid vaccine and a flu shot this year. The new vaccines from Pfizer and Moderna are specifically approved for people 12 and older and have emergency use authorization for children ages 6 months to 11 years.
Pfizer will begin shipping its new vaccine immediately and expects it to be available in pharmacies, hospitals and clinics across the U.S. “in the coming days,” the company said in a statement. Moderna also expects its vaccine to be available in a similar timeframe, according to a statement.
“Staying up to date with your COVID-19 vaccination remains one of the best ways for people to protect themselves and prevent severe disease,” Moderna CEO Stephane Bancel said in a statement. “We appreciate the U.S. FDA's timely review and encourage individuals to talk with their healthcare providers about whether they can receive their updated COVID-19 vaccine this fall in addition to their flu shot.”
Modern Covid-19 vaccine mRNA formula 2024-2025.
Politeness: Modern
The FDA approval came a few weeks before last year's round of vaccinations, which the agency approved on September 11.
The earlier availability of new vaccines could reassure Americans as the country experiences a relatively large surge in virus cases this summer. Nearly every state is finding “high” or “very high” levels of Covid in wastewater, according to CDC data. Wastewater monitoring provides insight into the spread of the virus in the U.S. as other testing methods have declined.
Other indicators of the virus are rising, but are still well below levels seen at the peak of the pandemic. According to the CDC, the positivity rate for Covid tests rose to 18.3% in the week ending August 10, up from 17.9% the previous week.
Meanwhile, the CDC said that in a given area, about four people per 100,000 people are hospitalized for Covid. That's up from about one Covid hospitalization per 100,000 people in May, the lowest level since the pandemic began.
By the time the vaccines reach patients and trigger an immune response against the virus, which usually takes two weeks after vaccination, the Covid-19 wave could subside in the summer.
Still, federal health officials have long warned Americans that Covid shots need to be updated annually because the virus is spawning new strains that can undermine the immunity people have from previous vaccinations or infections – protection that wanes over time. It's similar to the U.S., where new flu vaccines are rolled out every year.
It is unclear how many Americans will actually roll up their sleeves to get another vaccination in the coming months.
According to CDC data, as of early May, only about 22.5% of adults in the U.S. had received the final round of vaccinations from last fall.
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Many Americans who had received previous Covid vaccinations said they had not gotten the final booster shot because they were not as worried about the virus, according to a November survey by the health research organization KFF. Others said they had been too busy to get vaccinated, the survey found.
In June, the FDA initially asked vaccine makers to produce vaccines against JN.1 before telling them to focus on KP.2 instead “if possible.”
This shift seemed Novavaxwhich applied for approval of a new JN.1 vaccine in the same month, was at a disadvantage. The FDA did not approve the biotech company's vaccine.
In a statement, Novavax said it is working “productively” with the FDA as the agency completes its review. Novavax expects its vaccine to be approved in time for peak vaccination season in the U.S.
The company stated that its vaccine provides protection against descendants of JN.1, including KP.2.3, KP.3, KP.3.1.1 and LB.1.
Novavax makes protein-based vaccines that cannot be quickly adapted to a different virus strain. The protein-based technology is a decades-old method used in routine vaccinations against hepatitis B and shingles.
The Pfizer and Moderna vaccines use messenger RNA technology, which teaches cells to make proteins that trigger an immune response against Covid. The mRNA vaccines are much easier to develop and update than protein vaccines.
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