New agreement brings total supply to the European Union to 500 million doses, with delivery expected by the end of 2021
European Commission has the option to request an additional 100 million dosesPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the European Commission (EC) to supply an additional 200 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states. The EC has the option to request supply of an additional 100 million doses.
This new agreement is in addition to the 300 million doses that have already been committed to the EU through 2021 under the first supply agreement signed last year. The additional 200 million doses are expected to be delivered in 2021, with an estimated 75 million to be supplied in the second quarter.
The total number of doses to be delivered to the EU member states by the end of 2021 is now 500 million, with the potential to increase to 600 million based on the option granted in the new agreement.
“We recognize that more people must be vaccinated as soon as possible to help defeat this virus and control the global pandemic. We are working relentlessly to support the further roll-out of vaccination campaigns in Europe and worldwide by expanding manufacturing capacity,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With this new agreement with the European Commission, we now expect to deliver enough doses to vaccinate at least 250 million Europeans before the end of the year.”
“Broad access to well-tolerated and highly efficacious vaccines is essential to halt the pandemic. We have taken additional steps to expand our manufacturing capacity to two billion doses in 2021,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We will initiate production at our Marburg facility this month and have strengthened our manufacturing network with additional partners. We are continuing to evaluate, together with governments, authorities and partners at all levels, how we might address an even higher future supply requirement for our vaccines.”
COMIRNATY is being produced in BioNTech’s and Pfizer’s manufacturing sites in Europe. The distribution of COMIRNATY by the EU member states will continue to be determined according to the populations identified in EU and national guidance. Globally, Pfizer and BioNTech aim to manufacture approximately two billion doses in total by the end of 2021, assuming continuous process improvements, expansion at current facilities, adding new suppliers and contract manufacturers and updated six-dose labeling.
The vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorizations Holder in the EU, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.
AUTHORIZED USE IN THE EU:
COMIRNATY® ▼ (the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. The European Medicines Agency’s (EMA’s) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY®, 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.
The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY® may be lower in immunosuppressed individuals.
As with any vaccine, vaccination with COMIRNATY® 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.
There is limited experience with use of COMIRNATY® in pregnant women. Administration of COMIRNATY® in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
It is unknown whether COMIRNATY® is excreted in human milk.
Interactions with other medicinal products or concomitant administration of COMIRNATY® with other vaccines has not been studied.
Andrew Widger, photo BionTech