Pfizer, BioNTech Get Nod for COVID-19 Vaccine Booster from EU Panel

 Pfizer Inc. (NYSE: PFE, "Pfizer") and https://www.globenewswire.com/Tracker?data=nszWGAD-s8Kwh3AXFmnoQhf5wG71KUbSboLXclkoiHh-vbrb-E3SFCu3RX9qKmVWI97YwVFNBkYu6ZYdphsuyg== BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies' COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. If the EC grants the variation regarding a booster dose, the decision will be immediately applicable to all 27 EU member states.

The positive opinion by the CHMP is based on the clinical trial data shared by the companies, real world evidence as well as literature data. The data submitted by BioNTech and Pfizer include data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of COMIRNATY(R) . A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for COMIRNATY.

Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the EC. The companies do not expect the introduction of booster doses in the United States and the EU, if authorized, to impact the existing supply agreements in place with governments and international health organizations around the world.

COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing.

AUTHORIZED USE IN THE EU:

COMIRNATY(R) (the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from 12 years of age. The European Medicines Agency's (EMA's) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY(R), concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.

IMPORTANT SAFETY INFORMATION:

   -- Events of anaphylaxis have been reported. Appropriate medical treatment 
      and supervision should always be readily available in case of an 
      anaphylactic reaction following the administration of the vaccine. 
 
   -- Very rare cases of myocarditis and pericarditis have been observed 
      following vaccination with Comirnaty. These cases have primarily occurred 
      within 14 days following vaccination, more often after the second 
      vaccination, and more often in younger men. Available data suggest that 
      the course of myocarditis and pericarditis following vaccination is not 
      different from myocarditis or pericarditis in general. 
 
   -- Anxiety-related reactions, including vasovagal reactions (syncope), 
      hyperventilation or stress--related reactions (e.g. dizziness, 
      palpitations, increases in heart rate, alterations in blood pressure, 
      tingling sensations and sweating) may occur in association with the 
      vaccination process itself. Stress-related reactions are temporary and 
      resolve on their own. Individuals should be advised to bring symptoms to 
      the attention of the vaccination provider for evaluation. It is important 
      that precautions are in place to avoid injury from fainting. 
 
   -- The efficacy, safety and immunogenicity of the vaccine has not been 
      assessed in immunocompromised individuals, including those receiving 
      immunosuppressant therapy. The efficacy of COMIRNATY(R) may be lower in 
      immunosuppressed individuals. 
 
   -- As with any vaccine, vaccination with COMIRNATY(R) may not protect all 
      vaccine recipients. Individuals may not be fully protected until 7 days 
      after their second dose of vaccine. 
 
   -- In clinical studies, adverse reactions in participants 16 years of age 
      and older were injection site pain (> 80%), fatigue (> 60%), headache (> 
      50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and 
      injection site swelling (> 10%) and were usually mild or moderate in 
      intensity and resolved within a few days after vaccination. A slightly 
      lower frequency of reactogenicity events was associated with greater age. 
 
   -- The overall safety profile of COMIRNATY(R) in adolescents 12 to 15 years 
      of age was similar to that seen in participants 16 years of age and 
      older. The most frequent adverse reactions in clinical trial participants 
      12 to 15 years of age were injection site pain (> 90%), fatigue and 
      headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 
      20%). 
 
   -- There is limited experience with use of COMIRNATY(R) in pregnant women. 
      Administration of COMIRNATY(R) in pregnancy should only be considered 
      when the potential benefits outweigh any potential risks for the mother 
      and fetus. 
 
   -- It is unknown whether COMIRNATY(R) is excreted in human milk. 
 
   -- Interactions with other medicinal products or concomitant administration 
      of COMIRNATY(R) with other vaccines has not been studied. 
 
   -- For complete information on the safety of COMIRNATY(R) always make 
      reference to the approved Summary of Product Characteristics and Package 
      Leaflet available in all the languages of the European Union on the EMA 
      website. 

https://www.marketscreener.com/quote/stock/BIONTECH-SE-66771992/news/Press-Release-Pfizer-and-BioNTech-Receive-CHMP-Positive-Opinion-for-COVID-19-Vaccine-Booster-in-th-36596823/