Pfizer and BioNTech Submit EUA Request for an Additional Comirnaty Booster Dose in Adults Aged 65 and Older

News on March 20, 2022 /BioValleyBIOON/ --Pfizer(Pfizer) and BioNTech recently announced that they have submitted an application to the U.S. Food and Drug Administration (FDA) submitted an Emergency Use Authorization (EUA) application for the COVID-19 mRNA vaccine Comirnaty (BNT162b2):Administer Comirnaty as an additional booster dose for individuals aged 65 and older who have received an initial booster of any authorized or approved COVID-19 vaccine.

This EUA is based on two sets of real-world datasets from Israel, which were analyzed during the widespread transmission of the Omicron variant. The data shows,An additional dose of mRNA vaccine booster can enhance immunogenicity and reduce the incidence of confirmed infections and severe diseases.

Israel’s Ministry of Health analyzed records of more than 1.1 million elderly individuals aged 60 and above, who had no known history of SARS-CoV-2 infection and were eligible for an additional booster dose (fourth dose).These data show that, compared to individuals who received only one booster dose, those who received an additional Comirnaty booster dose at least four months after the initial booster (third dose) had a 2-fold reduction in confirmed infections and a 4-fold reduction in severe disease incidence.

The EUA also includes an ongoing, open-label, non-randomizedClinical TrialData. The trial was conducted at a single research center in Israel, with participants being 18 years old and above healthcare workers who had received three doses of Comirnaty. Among 154 participants (out of 700 total),In subjects who received an additional Comirnaty booster dose at least 4 months after the initial booster, neutralizing antibody titers increased approximately 7- to 8-fold two to three weeks after receiving the additional Comirnaty booster (fourth dose) compared to five months after receiving the initial booster (third dose).. In addition, inOne week and two weeks after receiving this dose of Comirnaty extra booster (4th dose), the neutralizing antibody titers against the Omicron variant (B.1.1.529) increased 8-fold and 10-fold, respectively, compared to five months after receiving the initial booster (3rd dose).This study also found that no new safety issues emerged among individuals who received an additional booster shot.

Continuously emerging new evidence, including data from Kaiser Permanente Southern California (KPSC), indicates that the effectiveness against symptomatic COVID-19 and severe illness caused by Omicron diminishes 3 to 6 months after receiving the initial booster (third dose). Therefore, an additional booster may be necessary to ensure individuals are adequately protected. Data from Israel, reviewed by the FDA, shows that receiving an extra booster dose of Comirnaty at least four months after the initial booster restores antibody titers to peak levels achieved after the third dose. This improves protection for individuals aged 60 and above in Israel against COVID-19 infection and severe disease, with a safety profile similar to prior doses. KPSC’s data was provided to the FDA as an example of waning efficacy of the Comirnaty vaccine but has not yet been...FDAReview.

Comirnaty Vaccine (Source: haber7.net)

The COVID-19 vaccine developed by Pfizer/BioNTech is based on BioNTech's proprietary mRNA technology and was co-developed by BioNTech and Pfizer. BioNTech is the marketing authorization holder in the United States, the European Union, and the United Kingdom, as well as the holder of Emergency Use Authorization (EUA) or equivalent authorization in the United States (together with Pfizer), Canada, and other countries. The two parties plan to submit applications in countries where EUA or equivalent authorization was initially granted to seek regulatory approval.

Comirnaty is a vaccine that has been approved in the United States.FDAThe approved COVID-19 vaccine, administered as a 2-dose immunization schedule, is indicated for the vaccination of individuals aged 16 years and older to prevent COVID-19.

The vaccine has also been granted Emergency Use Authorization (EUA): (1) a two-dose immunization schedule for vaccination of adolescents aged 12-15 to prevent COVID-19; (2) administration of a third dose for individuals aged 12 and above with weakened immune systems.

At the same time, the vaccine has also been granted an EUA as a single-dose booster for: (1) individuals aged 12 years and older who have completed a two-dose series of Comirnaty; (2) individuals aged 18 years and older who have completed a primary vaccination series with a different COVID-19 vaccine.

Clinical and real-world data continue to show that vaccinated individuals, especially those who have received booster shots, maintain high levels of protection, particularly against severe COVID-19 illness and hospitalization. Pfizer and BioNTech will remain vigilant, continue to gather data, and explore new vaccine approaches and regimens to reduce the risk of infection and severe COVID-19 disease. (Bioon.com)

Source of the original text:Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults