EU to Focus on mRNA Vaccines, Won’t Order Additional AstraZeneca Doses

The EU has made clear that it will set its sights on obtaining additional doses of Pfizer/BioNTech’s and Moderna’s mRNA-based COVID-19 vaccines, opting to pass on pursuing more doses of AstraZeneca (AZ)’s adenoviral-vector vaccine.

A European Commission (EC) spokesperson told FDAnews that the trade bloc will focus on obtaining mRNA vaccines to further combat the pandemic, citing the potential emergence of new viral variants that may hinder vaccines.

“At a certain point in time, we might need booster jabs to reinforce and prolong immunity, and if escape-variants occur, we will need to develop vaccines that are adapted to new variants. And we will need them early and in sufficient quantities,” the spokesperson said. “Having this in mind we need to focus on technologies that have proven their worth — mRNA vaccines are a clear case in point.”

Though the spokesperson noted the EU will still keep a “portfolio of different types of technologies, even if [it] is slightly more focused,” he said that the bloc will not exercise its contract option with AZ for additional doses.

The EU is reportedly also gearing up to sue the company over its failure to meet its supply deadlines, though the commission would not confirm any plans to sue. Reportedly, member states will have the choice of whether to participate in the litigation, with some expressing uncertainty about filing suit against the drugmaker.

“When it comes to AstraZeneca, what matters most now is that the company ensures the delivery of a sufficient number of doses in line with the company’s earlier commitments,” an EC spokesperson said in response to questions about a possible lawsuit.

For Johnson & Johnson (J&J)’s single-dose vaccine, ordering additional doses is still on the table for the EC and member states despite the bloc’s shift in focus.

While deliveries and usage of Pfizer/BioNTech’s and Moderna’s two-dose COVID-19 shots have gone off without issue in Europe, the same cannot be said for AZ’s and J&J’s vaccines. AZ’s European supply commitments have been plagued with delays, and the EC has blamed the Anglo-Swedish drugmaker for its slow vaccine rollout.

Additionally, both the AZ and J&J vaccines have caused concern over potential risks of rare blood clots, leading at least Denmark to drop the AZ jab after the EMA called for adding a warning to the vaccine’s product information. Most recently, a small number of blood-clot cases among patients who received the J&J vaccine in the U.S. temporarily delayed the drugmaker’s vaccine rollout in Europe just as it had gotten underway, though it has since resumed. Following its evaluation, the EMA recommended that the J&J vaccine should bear a warning for the risk of blood clots (DID, April 21).

The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices will meet today for the second time to discuss use of the J&J vaccine after use of it was paused in light of the blood-clot incidents and could give a similar recommendation.

Meanwhile Europe reportedly suffered another setback in obtaining COVID-19 vaccine doses after talks on a supply agreement failed this week with Valneva, a French biotech developing a coronavirus vaccine candidate. Reportedly, the EU was seeking to buy up to 60 million doses of the still unproven shot.

The Pfizer/BioNTech vaccine accounts for the majority of vaccine supplies in EU and European Economic Area (EEA) countries, with a total of 88.8 million doses distributed as of Thursday, according to EU data. Moderna has shipped 11.5 million doses to date in Europe, and CEO Stéphane Bancel has said that its slow negotiations with the EU put the trade bloc behind other countries seeking supplies of the shot.

To date, 31.2 million doses of AZ’s vaccine have been distributed to the bloc, while only 321,600 J&J doses have been delivered.

Despite its setbacks, the EU is still hopeful that its member states will have enough vaccine supplies to inoculate most of their populations by the end of June.

Jeff Zients, the White House’s COVID-19 response coordinator, has said that the U.S. has secured enough doses of the Pfizer/BioNTech and Moderna vaccines to inoculate 300 million Americans and meet the administration’s vaccination goals. This week, President Biden announced that the U.S. had hit its target of inoculating 200 million people during his first 100 days in office. — James Miessler