EU adds 100 million doses to Pfizer/BioNTech COVID-19 vaccine order The European Union has exercised its option, under a previous agreement, to order 100 million additional doses of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty.
This brings the number of doses ordered by the bloc up to 600 million, and is the largest cumulative supply agreement that Pfizer/BioNTech have made globally.
A total of 600 million doses represents enough to cover 300 million people: around two-thirds of the EU population. The vaccine will be supplied from BioNTech and Pfizer’s manufacturing sites in Europe.
Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“To date, we have met all of our supply commitments to the EC and we plan to deliver 250 million doses to the European Union in Q2, a four-fold increase on Q1’s agreed quantity.”
The European Medicines Agency’s safety committee (PRAC) says a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen: but says the benefit-risk analysis for the vaccine remains positive.
The rollout of the vaccine – which had been authorized for use in the EU on March 11 – was put on hold by J&J last week after it became aware of the blood clots. In the US, authorities also recommended a similar pause while the blood clot cases were investigated.
Issued today, the EMA notes the cases reviewed were very similar to those that occurred with
Emergent BioSolutions, a contract development and manufacturing organization (CDMO), has agreed with the US FDA not to manufacture any new COVID-19 vaccine materials at its Bayview facility in Baltimore, Maryland, while the regulator investigates the plant.
The company said the US Food and Drug Administration (FDA) began an inspection of the Baltimore site on April 12 and asked it to pause manufacturing four days later, pending completion of the review and remediation.
In a
filing to the US Securities and Exchange Commission (SEC), the CDMO also announced that it has quarantined all existing material manufactured at the facility.
Ingredient mix-up
A production issue at Emergent’s Baltimore plant late last month saw a massive batch of Johnson & Johnson’s COVID-19 vaccine doses spoiled. The CDMO had been producing both the J&J and AstraZeneca vaccines, but mixed up ingredients from the two, causing the loss of 15 million doses, according
US pharma group, Lilly, has requested the US FDA revoke the Emergency Use Authorization (EUA) for bamlanivimab 700 mg alone due to the evolving variant landscape in the US.
It said the request was not due to any new safety concern. Lilly moved quickly to make bamlanivimab alone available as a potentially lifesaving medicine at a time when Americans were hardest hit by COVID-19. With the growing prevalence of variants in the US that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” commented Daniel Skovronsky, Lilly s chief scientific officer and president of Lilly Research Laboratories, when explaining the rationale behind the move.