The FDA granted approval for Pfizer and Moderna’s new COVID vaccines, fast-tracking their distribution to the US amidst rising virus-related hospitalizations.
The FDA has granted approval for the new COVID vaccines, designed to combat the New Omicron variant XBB.1.5, for individuals aged 12 and above. As per an FDA statement, emergency use authorization has also been extended to children aged 6 months to 11 years old.
Americans will have to wait as Pfizer and Moderna’s new COVID vaccines won’t be immediately accessible. On Tuesday, a CDC advisory panel will convene to vote on a recommendation for the use of these vaccines.
Once approved by the CDC director, pharmacies, health clinics, and other distribution sites can administer the shots.
Novavax’s New COVID Vaccine Not Approved
In August, the Biden administration anticipated that Pfizer, Moderna, and Novavax would release single-strain vaccines against XBB.1.5 by mid-September.
On Monday, the FDA did not disclose its verdict regarding Novavax’s revised Covid vaccine. Following the approval of other new COVID vaccines, Novavax’s shares dropped nearly 13% in Monday’s trading.
Novavax employs protein-based technology, a long-established approach utilized in routine hepatitis B and shingles vaccinations. Pfizer and Moderna utilize messenger RNA to instruct cells in producing immune-triggering proteins against COVID-19.
New Vaccines will add reassurance
The increasing COVID cases and hospitalizations provide added reassurance with the arrival of updated vaccines for the American population. Although not designed for the current dominant variants, vaccine manufacturers assure that the shots will safeguard against these strains as children return to school and temperatures drop.
Following approval, Pfizer CEO Albert Bourla announced the imminent availability of this season’s vaccine, pending guidance from public health authorities. In a separate message, Bourla and Moderna CEO Stéphane Bancel emphasized the convenience of receiving the annual flu and upgraded COVID shots in one visit for Americans.
Hospitalization has increased
According to the CDC’s most recent data, hospitalizations have risen continuously for seven consecutive weeks, with a more than 15% increase during the week ending August 26, totaling 17,418.
This figure, however, remains lower than the summer 2022 surge, when hospitalizations surpassed 40,000 nationwide. The increase is driven by recently emerging strains closely linked to XBB.1.5, including EG.5 or Eris.
As of September 2, the CDC reported that Eris, an omicron variant, constituted 21.5% of all cases. Pfizer, Moderna, and Novavax have shared preliminary trial results affirming the efficacy of their updated vaccines against Eris.
Both Pfizer and Moderna affirmed that their updated shots elicited a potent immune reaction against BA.2.86, an omicron subvariant of significant concern to health authorities. The FDA pointed out that the COVID-19 boosters from Pfizer and Moderna administered last year are no longer approved in the United States.
The forthcoming vaccine distribution marks the first one following the conclusion of the US Covid public health emergency in May. The expiration of the declaration signals a transition in vaccine distribution to the private market.
Manufacturers will now sell their upgraded vaccines directly to healthcare providers at elevated prices. The change means the private market will play a central role in vaccine distribution, departing from the previous government-led distribution system.
Private insurers and government payers, including Medicare, are projected to offer vaccines at no cost to most Americans. Federal initiatives, like the Biden administration’s Bridge Access Program, intend to deliver free COVID-19 vaccinations to uninsured individuals.
Last week, White House press secretary Karine Jean-Pierre announced the Biden administration’s plan to encourage Americans to get a refreshed COVID-19 vaccine this autumn.
Jean-Pierre stated during a briefing that getting vaccinated against COVID-19 remains the most secure means to prevent hospitalization, long-term health issues, and fatalities.
The actual number of Americans willing to receive another shot in the coming months remains uncertain.
Since their approval in September 2022, Pfizer’s and Moderna’s latest boosters have been administered to just about 17% of the US population, or around 56 million people, according to the CDC.