Pfizer COVID-19 vaccine.
Courtesy: Pfizer
The Food and Drug Administration on Thursday approved updated COVID vaccines from Pfizer and ModernaThat puts new vaccines on track to reach most Americans in the coming days amid a summer surge in virus cases.
The vaccines target a strain called KP.2, a variant of the highly contagious Omicron JN.1 strain that began spreading widely in the United States earlier this year. KP.2 was the dominant Covid strain 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 said their KP.2 vaccines could produce stronger immune responses against other circulating subspecies of JN.1, such as KP.3 and LB.1, than last year's round of vaccines that targeted the Omicron XBB.1.5 strain.
“Given the population’s weakened immunity from prior exposure to the virus and prior vaccination, we strongly encourage those who are eligible to consider receiving the 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 Centers for Disease Control and Prevention recommended that everyone over 6 months old get a COVID-19 vaccine and a flu shot this year. The new vaccines from Pfizer and Moderna are specifically approved for people ages 12 and older and have been authorized for emergency use in children ages 6 months to 11 years.
Pfizer said in a statement that it will begin shipping its new vaccine immediately and expects it to be available in pharmacies, hospitals and clinics across the United States “starting in the coming days.” Moderna also expects its vaccine to be available in a similar timeframe, according to a statement.
“Staying up to date on the latest COVID-19 vaccine developments remains one of the best ways to protect people and prevent serious illness,” Moderna CEO Stéphane Bancel said in a statement. “We appreciate the FDA’s timely review and encourage individuals to talk to their healthcare providers about receiving the updated COVID-19 vaccine in addition to their flu vaccine this fall.”
Moderna COVID-19 mRNA Vaccine Formula 2024-2025.
Courtesy: Moderna
The FDA approval comes just weeks before last year's round of vaccines, which the agency approved on Sept. 11.
The early arrival of updated vaccines may offer some reassurance to Americans as the country experiences a relatively large spike in the virus this summer. According to data from the Centers for Disease Control and Prevention, “high” or “very high” levels of Covid are being detected in wastewater in nearly every state. Sewage surveillance provides a glimpse into the extent of the virus’s spread in the United States as other forms of testing have fallen behind.
Other measures of the virus are rising, but remain well below their peak. The COVID test positivity rate rose to 18.3% for the week ending Aug. 10, from 17.9% the week before, according to the Centers for Disease Control and Prevention.
Meanwhile, the Centers for Disease Control and Prevention 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 per 100,000 people in May, the lowest level since the pandemic began.
The summer Covid wave may subside by the time vaccines reach patients' arms and stimulate 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-19 vaccines as the virus produces new strains that can evade the immunity people have from vaccinations or previous infections — protection that wanes over time. That’s similar to how the United States rolls out new flu vaccines each year.
It's unclear how many Americans will actually be preparing for another chance in the coming months.
According to data from the Centers for Disease Control and Prevention as of early May, only about 22.5% of adults in the United States had received the latest round of vaccines issued last fall.
According to a November poll by the health policy research organization KFF, many Americans who had gotten previous doses of the Covid vaccine cited a lack of concern about the virus as a reason for not getting the latest booster shot. Others said they were too busy to get their shot, the poll said.
In June, the FDA asked vaccine manufacturers to make doses against JN.1 before telling them to target KP.2 instead “if feasible.”
This shift seems to have put Novavaxwhich applied for a new vaccine, JN.1, in the same month, is at a disadvantage. The FDA has not approved 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 authorized in time for the U.S. vaccination season.
The company noted that its vaccine provides protection against JN.1 strains, 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 technology is an old method that has been used for decades in routine vaccinations against hepatitis B and shingles.
Meanwhile, the Pfizer and Moderna 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 vaccines.