EU Grants Conditional Authorization to J&J Vaccine

The European Commission (EC) granted Johnson & Johnson (J&J)’s COVID-19 vaccine a conditional marketing authorization yesterday, giving the 27-member bloc a desperately needed alternative as the region faces serious supply delays for previously authorized shots.

The authorization, which immediately followed a positive opinion by the European Medicines Agency earlier in the day, means that distribution of 200 million J&J vaccine doses to EU member states will begin in the second quarter.

The single-dose J&J vaccine “takes us another step closer to achieving our collective goal of vaccinating 70 percent of the adult population by the end of summer,” said the commission’s president, Ursula von der Leyen.

J&J’s chief scientific officer, Paul Stoffels, reportedly said following the EU authorization that the company believes it can deliver on its 55 million dose commitment to the bloc in the second quarter.

Stoffels added that J&J anticipates manufacturing up to 3 billion vaccine doses in 2022 as long as it can successfully maximize capacity. In order to meet its immediate goal of delivering 1 billion doses by the end of this year, he said the company is tapping three manufacturing facilities to make the vaccine’s drug substance and will have seven global sites taking care of fill and finishing.

The EC has also negotiated supply deals for 600 million doses of the two-dose Pfizer/BioNTech vaccine, 460 million shots of the Moderna vaccine and 400 million of the AstraZeneca (AZ) vaccine. But the expected delivery of many of these doses — especially for AZ’s shot — has fallen behind schedule and EU member states are clamoring for additional supplies to inoculate the EU’s 448 million population.

The commission appears to have resolved the major delays with Pfizer/BioNTech and Moderna, but serious ongoing delays in delivery of the AZ vaccine have caused havoc among many member states and some are looking elsewhere for replacements, in some cases authorizing nonEU approved vaccines from Russia and China (DID, March 11).

Adding to Europe’s supply woes for the AZ shot, bloc officials reportedly said Thursday that the U.S. will not export any AZ vaccine doses made domestically to the EU at this time. The development comes as President Biden pledged this week that the U.S. would share any surplus of vaccines with the rest of the world (DID, March 11).

A Biden administration official told FDAnews that the government has not prohibited exports of any vaccines, stating that all vaccine manufacturers in the U.S. are free to export products as long as they still meet their U.S. contracts.

AZ’s vaccine has not been authorized in the U.S. and the company has yet to file for Emergency Use Authorization (EUA) with the FDA. It isn’t known how many doses AZ has manufactured in the U.S. to date.

Earlier in the pandemic, the U.S. government locked in 300 million doses of AZ’s vaccine through a $1.2 billion contract (DID, May 22, 2020).

The J&J vaccine, which received an FDA EUA in late February, demonstrated 85 percent efficacy against severe COVID-19 infection and 66 percent efficacy against moderate-to-severe COVID-19 in a global phase 3 trial with more than 44,000 participants (DID, March 1). ― Jason Scott