Updated Covid vaccines from Moderna and Pfizer were approved by the FDA.
Carlos Osorio/POOL/AFP via Getty Images
The Food and Drug Administration on Monday approved the updated Covid-19 vaccines from
Pfizer
and
Moderna,
clearing the way for shots to arrive at pharmacies as soon as this week.
The final regulatory step, a recommendation from the Centers for Disease Control and Prevention, could come following a meeting of the CDC’s vaccine advisors scheduled for Tuesday.
The FDA approved the Pfizer (ticker: PFE) and Moderna (MRNA) shots for people aged 12 and up, and issued an emergency use authorization for the shots in children aged six months through 11 years.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “We very much encourage those who are eligible to consider getting vaccinated.”
The agency said evidence shows the benefit-risk profile of the shots is favorable for individuals six months of age and up: “Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.”
The new shots target a variant called XBB.1.5, which is no longer prevalent in the U.S. The companies said their data show the shots generate neutralizing antibody responses to EG.5.1, which is currently the most widespread U.S. variant, and to BA.2.86, the variant that raised significant concerns when it emerged last month.
The FDA announcement didn’t mention
Novavax
(NVAX), which has also developed an updated Covid-19 vaccine. Unlike the Pfizer and Moderna vaccines, which use messenger RNA technology, the Novovax shot is protein-based. Novavax shares were down 6.2% on Monday.
The number of people being admitted to the hospital each day who are positive for Covid-19 is rising in the U.S., up 29% over the past two weeks, according to the New York Times. The numbers remain lower, however, than at any other point in the pandemic.
This year’s rollout marks a definitive transition to a commercial market for the Covid-19 vaccines. Previously, all Covid-19 vaccine doses distributed in the U.S. had been purchased by the federal government. Both Pfizer and Moderna have said the list prices of the shots will be between $110 and $130 per dose, though insurers will likely cover the shots with no copay.
Relatively few Americans are expected to choose to take the shots. Moderna and Pfizer both said early this year they projected the U.S. Covid-19 vaccine market would be 100 million doses this year, though Moderna dialed back that projection to between 50 million and 100 million doses in early August. Pfizer also has worked to tamp down expectations.
Those estimates would mean far fewer Americans get Covid-19 vaccines than influenza vaccines this year. Manufacturers distributed 173.4 million doses of flu vaccines in the U.S. during last year’s flu season, and the CDC says that 47.4% of Americans had been vaccinated for flu by late April, when the flu season ended.
Shares of both companies are down this year. Moderna stock has fallen nearly 40% since the start of the year, while Pfizer shares are down 33%, and shares of Pfizer’s partner
BioNTech
(BNTX) are down more than 20%. Both Pfizer and Moderna have discussed potential cuts to lower their spending on their Covid-19 programs. Analysts expect Moderna to lose $3.92 per share this year, and $5.11 per share next year, after earning $20.12 per share in 2022.
One lingering question is whether the CDC will recommend the Pfizer and Moderna shots for everyone over the age of six months, as they have in the past, or whether they will recommend it narrowly for older adults.
Write to Josh Nathan-Kazis at [email protected]
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