The Food and Drug Administration has given the go-ahead. Two updated COVID-19 vaccine booster shots Monday—the previous day Centers for Disease Control and Prevention advisors to meet and vote on the latest vaccine use recommendations.
The two shots are the 2023-2024 formulation of mRNA vaccines from Moderna and Pfizer-BioNTech, both of which target the recent Omicron subvariant XBB.1.5. The FDA has fully approved both Pfizer-BioNTech’s newest vaccine (Comirnaty) and Moderna’s newest vaccine (Spikevax) for use in people 12 years of age and older. The agency has issued emergency use authorizations for both updated vaccines for use in children aged 6 months to 11 years.
If the CDC and its advisers approve the vaccine for use on Tuesday, which is likely, the vaccine could be fully available at local pharmacies and clinics within days. The FDA timed today’s action to boost the population ahead of an expected winter surge, but the regulatory approval comes amid a slow increase in coronavirus infections that began in late summer. It was conducted.
“Vaccinations remain critical to public health and for continued protection from the serious consequences of COVID-19, including hospitalization and death,” Peter Marks, the FDA’s top vaccine regulator, said in a press release. ” he said. “The public can be confident that these latest vaccines meet the agency’s rigorous scientific standards for safety, efficacy, and manufacturing quality. We urge all eligible individuals to consider getting vaccinated. I recommend it.”
The FDA said in a statement that preliminary data from vaccinations show that neutralizing antibody responses to currently circulating variants, such as EG.5 and the highly mutated BA.2.86, are “comparable” to neutralizing antibodies. It was determined that there was a possibility of further promotion. Antibody responses seen with previous COVID-19 formulations targeting previous variants. Safety data also continues to be positive. Therefore, “the benefit-risk profile is favorable” for everyone 6 months of age and older to receive the updated vaccine, the FDA said.
in Monday’s statement, Moderna CEO Stephane Bancel thanked the FDA for its timely review and said an updated vaccine is “essential to protect the public” as the virus evolves. Meanwhile, Pfizer CEO Albert Bourla stressed that the number of new coronavirus infections is already increasing.
“Pending recommendations from public health officials, we expect this season’s vaccine to be available soon. That’s why people are seeing their doctors about getting the COVID-19 vaccine at the same appointment time as their annual flu shot. “You can ask, save time, and help prevent infection” to prevent serious illness after respiratory viruses reach their peak. ” Bourla said in a statement..
booster price
Early in the pandemic, the FDA moved to establish annual updates for COVID-19 vaccines and began booster immunizations in the fall alongside flu shots, ahead of an expected winter wave. This was despite many experts expressing concern that COVID-19 infections have not necessarily established seasonality. Nevertheless, the FDA is moving forward with its plans, and this will be the third fall booster rollout. However, this is the first time that the government will not pay for the vaccination costs.
This year, as COVID-19 vaccines moved from government distribution to the commercial market, Pfizer and Moderna significantly increased the price of their vaccines, increasing prices by about 400%. In recent vaccinations, the government spent about $26 to $30 for his single dose of the mRNA vaccine. But on the commercial market, the vaccine costs between $110 and $130. The increases have drawn intense criticism of price gouging, particularly against Moderna, which developed the vaccine in partnership with federal scientists and with the help of a $1.7 billion federal grant.
Assuming the CDC recommends the latest vaccines, most insured people will continue to have access to the vaccines without a co-pay. The federal government alsobridge access program” aims to provide free vaccines to the uninsured through December 2024.
Still, the widely criticized price increases are unlikely to help improve vaccination rates. So far, 17% of the US population (43% of people 65 and older) got the latest booster released in fall 2022.
Who should be strengthened?
There is also room for debate over who should receive the booster shot this year. Experts generally agree that boosters should be available to older adults and people with weakened immune systems. But some experts say it’s less clear, or at least less important, whether young, healthy people should get vaccinated. Vaccines primarily provide strong protection against severe illness and death, but young and healthy people are generally at lower risk. On the other hand, protection against infections and minor illnesses is weak and lasts only a few weeks to a few months.
Therefore, the benefit of vaccination for young, healthy people is lower. But some experts argue that a booster for everyone would help reduce infections among the most vulnerable. Young and healthy people are at lower risk than other groups, but they are not completely immune from serious illness and complications like long-term COVID-19 infection. Boosting can help protect you from such an outcome, even if it’s unlikely.
tomorrow’s meeting
The debate over who should get the vaccine will likely emerge next year. tomorrow’s advisory council– CDC’s Advisory Committee on Immunization Practices (ACIP) meeting. ACIP is a committee that sets recommended ages for vaccination.
ACIP will also discuss vaccines excluded from today’s FDA action. Novavax, a non-mRNA protein-based COVID-19 vaccine. Novavax has also developed an updated vaccine targeting XBB.1.5 for people 12 years of age and older. The company said in an announcement Monday that it is ready to roll out its updated shot, pending FDA clearance and CDC approval, but that it is “currently complying with the FDA’s request to expedite final review and the timing is Ultimately, it is up to discretion.” F.D.A. ”
