The Food and Drug Administration announced Thursday Covid vaccines updated and approved by Pfizer And ModernThat puts the new vaccines on track to reach most Americans in the coming days amid a summer surge in the virus.
The vaccines target a strain called KP.2, a descendant of the highly contagious Omicron JN.1 subvariant that began circulating widely in the United States earlier this year. KP.2 was the dominant strain of COVID in May but now accounts for only about 3% of all U.S. cases as of Saturday, according to the latest data from the Centers for Disease Control and Prevention.
However, Pfizer and Moderna have said their KP.2 vaccines may produce stronger immune responses against other circulating JN.1 subvariants, such as KP.3 and LB.1, than last year’s series of vaccines targeting the XBB.1.5 omicron strain..
“Given waning population immunity due to prior exposure to the virus and prior vaccination, we strongly encourage eligible individuals 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 get an updated COVID-19 vaccine and flu vaccine this year. The new vaccines from Pfizer and Moderna are specifically approved for people 12 and older and are authorized for emergency use for children 6 months to 11 years old.
Pfizer will begin shipping its new vaccine immediately and expects it to be available in pharmacies, hospitals and clinics across the United States “beginning in the coming days,” the company said in a statement. Moderna expects its vaccine to be available in the coming days, according to a statement.
“Staying up-to-date with your COVID-19 vaccine 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 FDA’s timely review and encourage people to talk to their healthcare providers about getting their updated COVID-19 vaccine at the same time as their flu vaccine this fall.”
The FDA approval comes just weeks before last year’s round of vaccines, which the agency authorized on Sept. 11.
The earlier arrival of new vaccines could reassure Americans as the country experiences a relatively large surge in the virus this summer. According to CDC data, “high” or “very high” levels of Covid are being detected in wastewater in nearly every state. Wastewater monitoring provides a snapshot of the extent of the virus in the United States, while other forms of testing have declined.
Other measures of the virus are rising, but remain well below what they were at the height of the pandemic. The Covid test positivity rate rose to 18.3% for the week ending Aug. 10, up from 17.9% the week before, according to the CDC.
At the same time, the CDC said about 4 people are hospitalized with Covid for every 100,000 people in a given area. That’s up from about 1 Covid hospitalization per 100,000 people in May, which was the lowest level since the pandemic began.
The summer wave of Covid could wane by the time vaccines reach patients’ arms and trigger an immune response against the virus, which typically takes two weeks after vaccination.
Still, federal health officials have long advised Americans to expect annual updates to Covid vaccines because the virus produces new strains that can evade 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 each year.
It’s unclear how many Americans will actually roll up their sleeves to get vaccinated again in the coming months.
According to CDC data through early May, only about 22.5% of American adults have received the latest round of vaccines that began last fall.
According to a November survey by the health policy research organization KFF, many Americans who had already received their COVID vaccine dose cited a lack of concern about the virus as the reason for skipping the latest shot. Others said they were too busy to get vaccinated, the survey found.
In June, the FDA asked vaccine makers to make vaccines against JN.1 before telling them to target KP.2 instead “if possible.”
This change seems to have put Novavaxwhich filed an application for authorization of a new JN.1 vaccine the same month, is at a disadvantage. The FDA has not authorized 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 receive authorization in time for the peak vaccination season in the United States.
The company noted 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, which can’t be quickly updated to target another strain of the virus. Protein-based technology is a decades-old method used in routine vaccinations for hepatitis B and shingles.
Meanwhile, Pfizer and Moderna’s vaccines use mRNA technology, which teaches cells how to make proteins that trigger an immune response against Covid. mRNA vaccines are much easier to develop and update than protein-based vaccines.
