Covid-19, Fda authorizes Pfizer / BioNTech and M bivalent boosters

Covid-19, Fda authorizes Pfizer / BioNTech and M bivalent boosters
Covid-19, Fda authorizes Pfizer / BioNTech and M bivalent boosters
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The FDA has cleared both Pfizer / BioNTech and Moderna’s bivalent booster vaccines with the aim of preventing the probable new wave of hospitalizations and deaths following Omicron’s new BA.5 sub-variant, which is expected to be dominant in the fall.

People 18 years of age or older can benefit from a single booster dose of the Moderna bivalent vaccine if it has been at least two months since they completed their primary vaccination or received the most recent booster dose with any monovalent Covid vaccine. 19. The same for Pfizer-BioNTech’s bivalent vaccine, except that it is licensed for a larger population, starting at age 12.

“Vaccines against Covid-19, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of the disease” said the FDA commissioner Robert Califf. “As we head into the fall and start spending more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent vaccine, to benefit from greater protection against the variants currently in use. circulation”.

Updated human data within the year
The decision raised some concerns about the actual greater efficacy of these updated vaccines, which partly include an mRNA component of the original Wuhan coronavirus strain and also an mRNA component of the BA.4 and BA.5 variants, compared to the original ones. considered that they are not supported by human data.

The director Peter Marks of the Center for Biologics Evaluation and Research (CBER), the center within the FDA that regulates biological products for human use under applicable federal laws, including public health, said the goal of updated versions of vaccines is increase the number of specific antibodies for the variant currently in circulation, in order to restore the protection provided by the initial vaccines. “We still don’t know for sure if we’ll get to the same level of protection, but that’s what we’re trying to do,” she explained.

He also pointed out that both companies are conducting the clinical trials necessary for the new data and that they will be available within a couple of months. Moderna said its Phase II / III clinical trial for this recall has completed enrollment, is currently underway, and first results are expected by the end of the year.

The UK, Switzerland and Australia have also authorized the updated boosters, even though they are based on the BA.1 strain.

The evidence that led to the authorization of bivalent boosters
For each bivalent vaccine against COVID-19the FDA decision was based on the totality of available evidence, including extensive safety and efficacy data relating to the original monovalent mRna vaccines, safety and immunogenicity data obtained from a clinical study of a bivalent vaccine that contained mRNA of the strain BA.1 of the Omicron variant.

The agency considers these data to be relevant and supportive to vaccines containing a component of the variants of Omicron BA.4 and BA.5. The two bivalent vaccines contain mRNA from the virus SARS-CoV-2, a specific fragment of genetic material that instructs the body’s cells to produce the characteristic “spike” protein of the original virus strain and the Omicron BA.4 and BA.5 strains. The spike proteins of BA.4 and BA.5 are identical.

Pfizer and BioNTech plan to apply to the FDA in early October for authorization for an Omicron-adapted bivalent vaccine for children aged 5-11 and are working to prepare an application for an Omicron-adapted bivalent vaccine as well. for children aged 6 months to 4 years.

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Data in support of the Moderna bivalent vaccine
To evaluate the efficacy of a single booster dose of the bivalent vaccine Modern, the FDA analyzed immune response data from approximately 600 individuals aged 18 and older who had previously received the two initial doses and a booster dose of the Moderna monovalent vaccine. Participants received a second booster dose of the Moderna monovalent vaccine or the Moderna bivalent experimental vaccine at least 3 months after the first booster dose. After 28 days, the immune response against BA.1 with the bivalent vaccine was superior to that developed with the monovalent vaccine.

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The safety of a single booster dose of Moderna bivalent vaccine is supported by safety data from a clinical study evaluating a booster dose of Moderna bivalent vaccine (original and omicron BA.1), safety data from clinical trials with primary and booster vaccination with Moderna monovalent vaccine and post-marketing safety data.

The clinical study evaluating the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 800 subjects aged 18 years or older who had previously received the two initial doses and a booster dose of the vaccine. Moderna monovalent and, after at least 3 months, a second booster dose with the Moderna monovalent or bivalent vaccine.

With the bivalent vaccine the most commonly reported side effects did not differ from those related to the monovalent vaccine and included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, swollen lymph nodes in the same arm as the injection. , nausea / vomiting and fever.

Data in support of Pfizer-BioNTech bivalent vaccine
To evaluate the efficacy of a single booster dose of the bivalent vaccine Pfizer-BioNTech In subjects 12 years of age or older, the FDA analyzed immune response data among approximately 600 adults over 55 who had previously received the two initial doses and a booster dose of the Pfizer-BioNTech monovalent vaccine. Participants received a second booster dose of Pfizer-BioNTech monovalent vaccine or bivalent vaccine (original and Omicron BA.1) 4.7 to 13.1 months after the first booster dose. After one month the subjects’ immune response against BA.1 was higher with the bivalent vaccine than with the monovalent.

The safety of a single booster dose of Pfizer-BioNTech bivalent vaccine in subjects 12 years and older is based on safety data from a clinical study that evaluated a booster dose of Pfizer-BioNTech bivalent vaccine (original and Omicron BA. 1), safety data from clinical trials evaluating primary and booster vaccination with Pfizer-BioNTech monovalent vaccine and post-marketing safety data.

The clinical study evaluating the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 600 participants over the age of 55 who had previously received the two initial doses and a booster dose of the vaccine. Pfizer-BioNTech monovalent vaccine and a second booster dose of Pfizer-BioNTech monovalent vaccine or bivalent vaccine (original and Omicron BA.1) 4.7 to 13.1 months after the first booster dose.

With the bivalent vaccine the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.

The article is in Italian

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