FDA approves updated Pfizer, Moderna Covid vaccines as virus surges; shots to be available within days
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 expects its shot to 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.”
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.
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