According to three people with knowledge of the situation, the FDA is set to approve a pair of booster injections targeting what appear to be the virus' most infectious strains as soon as Wednesday.
The action would pave the way for the Biden administration to begin selling the reformulated vaccine shortly after Labor Day, to safeguard Americans from a potential Covid comeback later this year.
US To Distribute New COVID-19 Vaccine Boosters
According to a federal planning guide issued earlier this month, the government intends to distribute 175 million doses of the new boosters created by Moderna and Pfizer-BioNTech, with Moderna's shot available to all adults and Pfizer's shot given to those 12 and older.
The boosters, which authorities think will provide stronger protection against the BA.4 and BA.5 Omicron sub-variations as well as the original coronavirus strain, come as the government strives to stay ahead of a virus that continues to infect tens of thousands of Americans every day. Because so many people self-test at home and do not disclose their cases to the government, the exact number is unclear.
Last week, both Moderna and Pfizer-BioNTech submitted their authorization applications. Some public health experts have questioned whether the administration should authorize and roll out the boosters without first conducting human trials to demonstrate their efficacy, according to Politico.
According to medical experts, the comparison with flu vaccinations is flawed since flu viruses evolve so quickly that injections from one year don't protect the next, but currently existing COVID-19 doses keep individuals out of the hospital. In addition to examining the boosters in the absence of clinical trial data, the FDA will not hold a conference of experts who will give recommendations on whether the agency should sanction a shot.
COVID-19 Vaccine's Effectiveness Against Omicron Subvariants
Even though the viruses that were designed to battle are developing, the COVID-19 vaccines presently available in the United States, which were approved for use in December 2020, have not been altered. While the injections still worked against more established strains, they were less successful against new Omicron subvariants like BA.5, as per WIO News.
Pfizer made their FDA filing one day before Moderna. The organization is also ahead in a few other areas. Pfizer received a $3.2 billion order from the United States to provide 105 million vaccine doses. This includes both the initial vaccination and the Omicron-specific booster. The nation can acquire an extra 195 million doses.
The United States may eventually purchase the same amount of doses (300 million) from Moderna and Pfizer. But, for the time being, Pfizer has a larger share of the market.
The population to be vaccinated is another benefit for Pfizer. It is asking permission to be used in people aged 12 and up. As a result, Pfizer may maintain its advantage in teen vaccination. The FDA approved Pfizer's initial adolescent vaccination roughly a year before Moderna's, giving it a considerable first-to-market advantage. Older individuals have been more sensitive to coronavirus - and competitor Moderna has previously stated that at-risk populations are the core audience for boosters. However, use in younger groups can increase income over time.
Pfizer, like Moderna, has offered to swiftly update vaccinations and/or boosters as needed. And both firms' usage of mRNA technology makes this feasible. This is because mRNA vaccines do not require the extensive processes involved with conventional vaccine production, The Motley Fool via MSN reported.
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