A health-care worker prepares a dose of the Covid-19 vaccine at a vaccination clinic in Peabody, Massachusetts.
Vanessa Leroy | Bloomberg | Getty Images
The Food and Drug Administration (FDA) has given its approval for updated Covid vaccines from Pfizer and Moderna, as hospitalizations from the virus continue to rise in the United States.
The new vaccines, which are targeted towards the omicron variant XBB.1.5, have been authorized for individuals aged 12 and older. Emergency use authorization has also been granted for children between the ages of 6 months and 11 years, according to a statement released by the FDA.
However, it’s important to note that the updated vaccines from Pfizer and Moderna will not be immediately available to the general public in the United States.
The Centers for Disease Control and Prevention (CDC) advisory panel is scheduled to meet on Tuesday to vote on a recommendation for the use of these vaccines. Once the CDC director approves these recommendations, the shots can be administered at pharmacies, health clinics, and other vaccine distribution sites.
In August, the Biden administration announced that it expected the new single-strain vaccines from Pfizer, Moderna, and Novavax to be available to the public by mid-September, specifically targeting the XBB.1.5 variant.
The FDA, however, did not announce a decision on an updated Covid shot from Novavax. Novavax has stated that its vaccine is still under review by the agency. Following the FDA’s approval of the updated vaccines from Pfizer and Moderna, Novavax’s shares fell by nearly 13%.
It is worth noting that Novavax’s vaccine uses protein-based technology, which is a method that has been used for decades in routine vaccinations against hepatitis B and shingles. On the other hand, Pfizer’s and Moderna’s shots use messenger RNA, which instructs cells on how to produce proteins that trigger an immune response against Covid.
The availability of updated vaccines provides some reassurance to Americans as the country experiences a rise in Covid cases and hospitalizations.
While the vaccines may not specifically target the currently dominant variants, the manufacturers have stated that they still offer protection against these strains, especially as children return to school and the weather gets cooler.
“We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities,” said Pfizer CEO Albert Bourla in a statement.
In a separate statement, Moderna CEO Stéphane Bancel urged Americans to receive their updated Covid shot along with their annual flu shot.
Hospitalizations have been increasing for the past seven weeks, with a more than 15% rise in the week ending August 26, reaching a total of 17,418, according to the latest data from the CDC. However, this number is still lower than the surge witnessed in the summer of 2022, when hospitalizations exceeded 40,000.
The increase in hospitalizations is mainly fueled by newer strains of the virus that are closely related to XBB.1.5, such as EG.5 or Eris. According to the CDC, the omicron strain accounted for 21.5% of all cases as of September 2, while XBB.1.5 is declining in the U.S.
Residents receiving Covid-19 booster shots at a vaccine clinic in Lansdale, Pennsylvania.
Hannah Beier | Bloomberg | Getty Images
Pfizer, Moderna, and Novavax have released early trial data indicating that their new shots provide protection against Eris.
Both Pfizer and Moderna have also reported that their updated shots generate a strong immune response against BA.2.86, a highly mutated omicron subvariant that health officials are closely monitoring.
“The updated vaccines are expected to provide good protection against Covid-19 from the currently circulating variants,” stated the FDA in its release on Monday.
The FDA also mentioned that the Covid boosters from Pfizer and Moderna that were used last year are no longer authorized in the U.S.
The upcoming rollout of the vaccines will be the first since the end of the U.S. Covid public health emergency, which expired in May.
As a result, vaccine distribution will transition to the private market, where manufacturers will sell their updated shots directly to healthcare providers at higher prices. Previously, the government purchased vaccines from manufacturers at a discount to distribute them to all Americans for free.
Private insurers and government payers, such as Medicare, are expected to provide the vaccines to individuals at no charge. Federal programs, including the Biden administration’s Bridge Access Program, aim to offer free Covid shots to uninsured individuals.
The Biden administration plans to encourage Americans to receive an updated Covid shot this fall, according to White House press secretary Karine Jean-Pierre.
“Vaccination against Covid-19 remains the safest protection against hospitalization, long-term health issues, and death,” Jean-Pierre stated during a briefing.
However, it is uncertain how many Americans will choose to get vaccinated in the coming months. According to the CDC, only around 17% of the U.S. population, or approximately 56 million people, have received the latest boosters from Pfizer and Moderna since their approval in September 2022.
