The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization (cMA) for a 30-g booster dose of Pfizer Inc. and BioNTech SE’s Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY Original/Omicron BA.4/BA.5 15/15 g) for individuals 12 years of age and older. The CHMP recommendation will be examined by the European Commission, which is anticipated to reach a conclusion soon.
The Omicron BA.4/BA.5-adapted bivalent vaccination comprises 15 g of mRNA encoding both the spike protein of the Omicron BA.4/BA.5 subvariants and the wild-type spike protein of SARS-CoV-2 in the original Pfizer-BioNTech COVID-19 vaccine. All other elements of the vaccine are the same, with the exception of the insertion of the BA.4/BA.5 spike protein’s mRNA sequence.
“This recommendation marks another major milestone in the ongoing global fight against COVID-19, bolstering our defenses as we prepare for fall and winter with potential increased exposure to the virus”, “Due to our multifaceted approach helping to address emerging variants and subvariants of concern, public health authorities in the EU will have our bivalent booster options, pending authorization, to facilitate flexible vaccination strategies for maximal coverage across the region.”
Albert Bourla, Chairman and Chief Executive Officer, Pfizer
“If the European Commission follows today’s recommendation by the CHMP, EU residents will have access to Omicron-adapted vaccines before the start of the winter season”, “The bivalent vaccines encode the spike protein of the SARS-CoV-2 wild-type as well as a spike protein of an Omicron subvariant. They aim to provide broader immunization against COVID-19 caused by the current dominant Omicron sublineages and previous variants of concern.”
Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech
The World Health Organization (WHO), the European Medicines Agency (EMA), and the International Coalition of Medicines Regulatory Authorities (ICMRA) have all issued recommendations to advance bivalent vaccine candidates in order to make an Omicron-adapted vaccine as soon as possible available to member states of the European Union (EU). Based on pre-clinical and manufacturing data from the Omicron BA.4/BA.5-adapted bivalent vaccine as well as data from Pfizer’s and BioNTech’s Omicron BA.1-adapted bivalent vaccine, the CHMP has recommended the Omicron BA.4/BA.5 bivalent COVID-19 vaccine. The Omicron BA.1-adapted bivalent vaccine developed by Pfizer and BioNTech evoked a better immune response against the Omicron BA.1 subvariant than the firms’ current COVID-19 vaccine, according to clinical results from a Phase 2/3 trial. It also had a better safety profile. A booster dose of the BA.4/BA.5-adapted bivalent vaccine also produced a potent neutralising antibody response against the Omicron sublineages, including the BA.1, BA.2, BA.4, and BA.5 subvariants, as well as the original virus, according to pre-clinical data, while maintaining a favourable safety profile.
The Pfizer-BioNTech bivalent Omicron BA.4/BA.5 COVID-19 vaccine will be made available to all 27 EU member states supporting the European vaccination campaigns in the coming days, assuming an authorization is granted. Depending on the demands of each separate government, local supply may change. An Omicron BA.1-adapted bivalent COVID-19 vaccine was approved for conditional marketing in the EU at the beginning of September by Pfizer and BioNTech. The U.S. Food and Drug Administration also approved an Omicron-adapted vaccine based on the BA.4/BA.5 subvariant as a booster for those aged 12 and older on August 31, 2022.
In the upcoming weeks, the businesses also want to submit the data to additional regulatory agencies, including the FDA and the EMA, in order to draught an application for a bivalent vaccination designed for Omicron in children under the age of 12.
Both BioNTech and Pfizer worked together to develop the Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s unique mRNA technology. In addition to holding emergency use authorizations or their equivalents in the United States (jointly with Pfizer) and other nations, BioNTech is the marketing authorization holder for BNT162b2 (COMIRNATY) in the United States, the European Union, the United Kingdom, Canada, and other nations. In those nations where emergency use authorizations or the equivalent were initially granted, submissions to pursue regulatory approvals are planned.
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) AUTHORIZED USES
The FDA has granted Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) for use in people 12 years of age and older as a single booster dose given at least two months following one of the following:
- completion of primary immunisation with any monovalent COVID-19 vaccine that has been authorised or approved
- receipt of the most recent booster dose of any monovalent COVID-19 vaccination that has been authorised or licenced.
All of your medical issues should be disclosed to your vaccine provider, especially if you:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the immune system
- are pregnant, plan to become pregnant, or are breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
- COMIRNATY® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) may not protect all vaccine recipients.
- You should not receive Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) if you have had a severe allergic reaction to after a previous dose of COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID 19 Vaccine or had a severe allergic reaction to any ingredient in these vaccines
- There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital
Immediately seek medical care if you experience any of the following signs:
- difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
- Some recipients of COMIRNATY® (mRNA) or Pfizer-BioNTech COVID-19 Vaccine have had myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining surrounding the heart). The observed risk is highest in boys 12 to 17 years of age, and it is higher in adolescent males and adult males under the age of 40 than it is in females and older males. Most of these individuals developed symptoms within a week of receiving their first or second booster dose, with most booster doses being given at least five months after the initial vaccine series was finished. The likelihood of this happening is quite slim.
Following are some of the side effects associated with these vaccines:
- Tiredness
- Headache
- Muscle pain
- Chills
- Joint pain
- Fever
- Severe allergic reactions
- Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Injection site pain
- Tiredness
- Headache
- Muscle pain
- Chills
- Joint pain
- Fever
- Injection site swelling
- Injection site redness
- Fainting in association with injection of the vaccine
- Unusual and persistent irritability
- Unusual and persistent poor feeding
- Unusual and persistent fatigue or lack of energy
- Unusual and persistent cool, pale skin
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Diarrhea
- Vomiting
- Arm pain
