EMA Recommends AZ Vaccine as European Commission Publishes Contract Amid Export Block Row

Date: February 1, 2021 | Country: BELGIUMUNITED KINGDOM | Region: EU27 + UKEUROPE | 
Type: Drug Approval | Keywords: #astrazeneca #commission #covid-19 #european #union #vaccine

PRICENTRIC BRIEF:

  • On Friday, the European Commission published its redacted contract with AstraZeneca (AZ) for the company’s COVID-19 vaccine, on the same day that the European Medicines Agency (EMA) recommended approval for the UK-grown vaccine
  • In a bid to protect its own citizens and mitigate the supply issues, on Friday, the EU also passed a new regulation that introduces export controls on Europe-produced vaccines; including the Pfizer shot produced in Belgium that is a prime part of the UK’s vaccinations strategy
  • The legislation essentially allows countries in the bloc to deny authorization for vaccine exports if the company making them has not honored existing contracts with the Union

THE DETAILS

BRUSSELS, Belgium – On Friday, the European Commission published its redacted contract with AstraZeneca (AZ) for the company’s COVID-19 vaccine, on the same day that the European Medicines Agency (EMA) recommended approval for the UK-grown vaccine.

President of the Commission, Ursula von der Leyen, agreed with the publication, stating that it contained “binding orders,” contrary to AZ CEO Pascal Soirot’s insistence that the document is “not a commitment,” but rather more of a promise to fulfill its “best effort.”

Speaking in an interview with German radio on Friday morning, von der Leyen explained: “We know exactly what’s in the contract and that’s why it’s important for us to make it public.”

“It’s not like standing in the line at the bakery, it’s a clear contract. This is about millions of euros that were invested in advance by the European Union.”

EMA Greenlight

The move came on the same day that the EMA recommended granting a conditional marketing authorization for the vaccine, making it the third COVID-19 vaccination to be approved in the EU.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA. “As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”

Vaccine Export Restrictions

In a bid to protect its own citizens and mitigate the supply issues, on Friday, the EU also passed a new regulation that introduces export controls on Europe-produced vaccines; including the Pfizer shot produced in Belgium that is a prime part of the UK’s vaccinations strategy.

The legislation essentially allows countries in the bloc to deny authorization for vaccine exports if the company making them has not honored existing contracts with the Union.

This primarily means AstraZeneca and Pfizer, as Pfizer also informed the Commission on Friday 15 January that it wasn’t able to fulfill all of the promised deliveries in the coming three to four weeks due to upscaling production at its facilities.

Von der Leyen noted on the implementation of the rule, “Protecting the health of our citizens remains our utmost priority, and we must put in place the necessary measures to ensure we achieve this. This transparency and authorization mechanism is temporary, and we will of course continue to uphold our commitments towards low and middle-income countries.”

The Union noted that there are exceptions to the scheme, particularly for lower-income countries.

The Background

In January AZ informed the European Commission that there would be a substantial delay in deliveries of its COVID-19 vaccine throughout the first quarter of the year.

In a statement, the company explained, “While there is no scheduled delay to the start of shipments of our vaccine should we receive approval in Europe, initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain. We will be supplying tens of millions of doses in February and March to the European Union, as we continue to ramp up production volumes.”

Despite the delays, AZ confirmed that the UK would not be affected.

The 60% decrease in deliveries brings the number of doses scheduled to arrive in the European Union (EU) in the first quarter to around 30 million, significantly fewer doses than outlined in the pre-purchase agreement.

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