Pfizer announced on 29 March 2022 that the FDA in the US has expanded the emergency utilisation of their vaccine to include an additional COVID-19 vaccine booster dose in adults aged 50 and over.
The FDA also has authorised an additional COVID-19 vaccine booster dose for individuals 12 years of age and older who are immunocompromised and have also received a first booster dose of any authorised COVID-19 vaccine.
The additional booster is to be administered at least four months after the first booster and is the same formulation and strength as prior Pfizer-BioNTech COVID-19 vaccine doses.
How have officials come to this decision?
The expanded EUA is based on the totality of scientific evidence shared by the companies. This includes immunogenicity data from an ongoing, open-label study, which consists of 154 healthcare workers 18 years and older, at a single centre in Israel who have received two booster doses during a period when Omicron was the predominant variant.
Scientists noted an approximately 11-fold increase in geometric mean, neutralising antibody titers against wild-type viruses. Both Delta and Omicron variants were reported at two weeks after the second booster as compared to five months after the first booster dose.
Researchers observed that no new safety concerns were noted among study participants. The companies also shared with the FDA data from the US and elsewhere showing a decline in vaccine effectiveness against COVID-19 three-six months after the initial booster, and evidence from Israel revealed that an additional COVID-19 vaccine booster can improve an individual’s protection against severe disease and death.
What was observed from the results of this study?
This data demonstrates the public health requirement for an additional COVID-19 vaccine booster of the Pfizer-BioNTech COVID-19 vaccine. This should be administered at least four months after the initial booster to maximise the potential restoration of antibody levels, improve protection in older people, and provide a similar safety profile to that of previous doses.
Thus, this highlights the importance of considering an additional booster dose for all individuals included in this EUA.
The Pfizer-BioNTech COVID-19 vaccine was previously authorised under EUA as a single booster administered to individuals aged 12 years and older who have completed the primary vaccination series with the Pfizer-BioNTech COVID-19 vaccine, as well as to individuals aged 18 years and older who have completed primary vaccination with another authorised or approved COVID-19 vaccine. The additional COVID-19 vaccine booster authorised today for those aged 50 years and older is meant to extend high levels of protection against the virus, for those who are considered to be the most vulnerable populations, in advance of potential future waves.
The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorisation Holder in the US, the EU, the UK, Canada, and the holder of emergency use authorisations or equivalents in the US (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorisations or equivalent were initially granted are planned.
How will the additional COVID-19 vaccine booster be administered?
The vaccine will be given as an injection into the muscle.
Primary Series:
In individuals five years of age and older, the vaccine is administered as a two-dose series, three weeks apart. In individuals five years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to be immunocompromised.
Booster Dose:
- A first booster dose of the vaccine may be administered at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 vaccine or COMIRNATY (COVID-19 vaccine, mRNA) to individuals 12 years of age and older;
- A first booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with another authorised or approved COVID-19 vaccine. Individuals should check with their healthcare provider regarding the timing of the booster dose;
- A second booster dose may be administered to individuals who are 50 years and older at least four months after receipt of a first booster dose of any authorised COVID-19 vaccine; and
- A second booster dose of the vaccine may be administered at least four months after receipt of a first booster dose of any authorised COVID-19 vaccine to individuals 12 years and older, who have been determined to have certain kinds of immunocompromise.
How do you know if you qualify for this dose?
The FDA-approved COMIRNATY and the EUA-authorised Pfizer-BioNTech COVID-19 vaccine have the same formulation and can be utilised interchangeably. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness.
The Pfizer-BioNTech COVID-19 vaccine has received EUA from FDA to provide:
- A two-dose primary series for individuals five years of age and older;
- A third primary series dose to individuals five years of age and older who have been determined to have certain kinds of immunocompromise;
- A single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 vaccine or COMIRNATY;
- A single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorised or approved COVID-19 vaccine. The booster schedule is based on the labelling information of the vaccine used for the primary series;
- A second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorised COVID-19 vaccine; and
- An additional COVID-19 vaccine booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorised COVID-19 vaccine.
COMIRNATY is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a two-dose series for the prevention of COVID-19 in individuals 16 years of age and older. It is also authorised under EUA to provide:
- A two-dose primary series for individuals 12 through 15 years of age;
- A third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise;
- A single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 vaccine or COMIRNATY;
- A single booster dose to individuals 18 years and older who have completed primary vaccination with another authorised or approved COVID-19 vaccine. The booster schedule is based on the labelling information of the vaccine used for the primary series;
- A second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorised COVID-19 vaccine; and
- An additional COVID-19 vaccine booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorised COVID-19 vaccine.
