Comirnaty: Pfizer/BioNTech new COVID-19vaccine for the elderly

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Comirnaty: Pfizer/BioNTech new COVID-19vaccine for the elderly

Pfizer/BioNTech COVID-19 mRNA vaccine: Comirnaty as an additional booster dose for the elderly ≥ 65 years old!

ImagePfizer and BioNTech recently announced that they have submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration ( FDA ) for the COVID-19 mRNA vaccine Comirnaty (BNT162b2): Comirnaty as an additional booster dose with Seniors 65 and older who have received an initial booster shot of any licensed or approved COVID-19 vaccine.

The EUA is based on 2 sets of real-world datasets from Israel that were analyzed when the Omicron variant strain was widespread.

The data showed that an additional booster dose of the mRNA vaccine could improve immunogenicity and reduce the incidence of confirmed infections and serious illness.

The Israeli Ministry of Health analyzed records of more than 1.1 million people aged 60 years and older who had no known history of SARS-CoV-2 infection and were eligible for an additional booster shot (dose 4).

These data show that individuals who received an additional booster dose of Comirnaty after at least 4 months of the initial booster (dose 3) had a 2-fold lower incidence of confirmed infections compared to individuals who received only one booster dose , the incidence of serious disease decreased by 4 times.

Data from an ongoing, open-label, non-randomized clinical trial were also included in the EUA .

The trial was conducted at a single study center in Israel and included healthcare workers 18 years of age and older who had received 3 doses of Comirnaty.

Among 154 subjects (700 total) who received an additional booster dose of Comirnaty at least 4 months after the initial booster, 2 and 3 weeks after receiving this additional booster dose of Comirnaty (dose 4), Neutralizing antibody titers increased approximately 7- to 8-fold compared to 5 months after receiving the initial booster (dose 3) .

In addition, at 1 and 2 weeks after receiving this additional booster shot of Comirnaty (dose 4), compared with 5 months after receiving the initial booster shot (dose 3), for the Omicron variant (B.1.1. 529) were increased by 8-fold and 10-fold, respectively .

The study also found no new safety concerns among individuals who received the extra booster shots.

Emerging evidence, including data from the Kaiser Permanente Healthcare Group of Southern California (KPSC) in the US, shows that after an initial booster shot (3rd dose), efficacy against symptomatic COVID-19 and severe illness caused by Omicron will not be It subsides after 3-6 months.

Therefore, additional booster needles may be required to ensure that the individual is adequately protected. Data from Israel and reviewed by the FDA show that an additional booster dose of Comirnaty administered at least 4 months after the initial booster restores antibody titers to peak titer levels after the third dose, which increases the likelihood of a 60 Protection against COVID-19 infection and serious illness for individuals aged 12 years and older with a similar safety profile to previous vaccinations. Data from the KPSC was provided to the FDA as an example of the waning efficacy of the Comirnaty vaccine, but has not been reviewed by the FDA .

Comirnaty vaccine (Image source: haber7.net)

Pfizer/BioNTech’s COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology, co-developed by BioNTech and Pfizer.

BioNTech is the holder of a marketing authorization in the United States, the European Union and the United Kingdom, as well as the holder of an Emergency Use Authorization (EUA) or equivalent authorization in the United States (along with Pfizer), Canada and other countries.

The parties plan to submit applications for regulatory approval in the countries where the EUA or equivalent authorization was originally granted.

Comirnaty is a COVID-19 vaccine that has been approved by the US FDA as a 2-dose immunization program for the immunization of people 16 years of age and older against COVID-19.
The vaccine has also been granted an Emergency Use Authorization (EUA) for:

(1) a 2-dose immunization program for the immunization of adolescents aged 12-15 to prevent COVID-19;

(2) for use in immunocompromised individuals aged 12 and older population, provide a third dose of immunization.

At the same time, the vaccine was also granted an EUA as a single-dose booster:

(1) for people 12 years of age and older who have completed the Comirnaty 2-dose immunization schedule;

(2) for people who have completed immunization with a different COVID-19 vaccine Program for people aged 18 and over.

Clinical and real-world data continue to show that vaccinated individuals, especially those who received booster shots, maintain high levels of protection, especially with regard to severe illness and hospitalization from COVID-19.

Pfizer and BioNTech will remain vigilant and continue to collect data and explore new vaccine pathways and regimens to reduce the risk of infection and the risk of severe COVID-19 disease.

Reference：

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

Comirnaty: Pfizer/BioNTech new COVID-19vaccine for the elderly

(source:internet, reference only)

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