BRUSSELS (Reuters) – The European Union expects Novavax to submit data needed for the possible approval of its COVID-19 vaccine around October, an EU official told Reuters on Friday, in what could be another delay for the U.S. biotech firm.
Novavax signed a deal with the EU this month to supply up to 200 million doses and said it would complete the submission of data to the European Medicines Agency (EMA) for the vaccine’s approval in Europe as early as the end of September.
“We expect data around October, but we are not sure about the precise timing,” an EU official familiar with the process said under condition of anonymity as the matter is confidential.
“It’s all very uncertain,” the official said, noting that further delays were possible. However, the source said a decision on the vaccine approval was still possible this year, “as long as there are no more delays”.
Novavax said in its most recent earnings announcement that it planned to submit its data to the EU “within weeks” of its filing to British regulators, setting the likely timeline between late September and early October, a spokesperson said.
“We are confident in this timeline and the progress that’s underway,” the spokesperson said in an email to Reuters on Friday.
EMA declined to comment on the matter because it said its assessment of the vaccine was still under way.
Novavax’s protein-based vaccine uses alternative technology to the four shots already approved in the EU. The Pfizer/BioNTech and Moderna vaccines use messenger RNA (mRNA) technology while the AstraZeneca and Johnson & Johnson shots are based on viral vectors.
That makes the Novavax jab more interesting to the EU, which is seeking to diversify its portfolio of vaccines.
U.S. DELAYS
Earlier in August, Novavax delayed its timeline for seeking U.S. authorisation for its two-dose vaccine, pushing it back to the last quarter of this year from the third. The company has filed for regulatory authorisation for its shot in India, Indonesia and the Philippines.
The EU official said Novavax needed to submit information on so-called chemistry, manufacturing and controls (CMC) and that had been delayed because Novavax has changed its production strategy. Those changes have complicated the clearing by regulators of its manufacturing sites which need authorisation before the vaccine is placed on the market, the official said.
The source said it was now harder to demonstrate that the vaccine used in clinical trials was the same as the one that would be produced for mass consumption.
EMA is also still assessing the vaccine’s clinical data under a rolling review that was launched in February.
Novavax and the EU reached a preliminary deal in December for the supply of the vaccine but due to regulatory and production issues the final contract was only signed this month.
The EU Commission, which coordinates talks with vaccine makers together with EU governments, has said it expected the first Novavax doses to arrive this year.
(Reporting by Francesco Guarascio @fraguarascio; Additional reporting by Carl O’Donnell; Editing by David Clarke)
