More COVID-19 Vaccine Contenders in Race for Approval

Multiple COVID-19 vaccine developers are expected to file for regulatory approval in the coming months as the global pandemic continues its relentless advance.

Though many supply deals are in place for all the approved vaccines, governments around the world are still going to need access to billions more vaccine doses to inoculate their entire populations.

The EU has already negotiated advance orders for vaccines from Pfizer/BioNTech, Moderna, AstraZeneca (AZ), Sanofi/GlaxoSmithKline (GSK), Johnson & Johnson (J&J) and Curevac, while the U.S. has forged supply deals with Pfizer/BioNTech, Moderna, Sanofi/GSK, J&J and Novavax.

Several vaccines have received conditional marketing or Emergency Use Authorizations (EUAs) — including Moderna’s, which was approved by the EU and UK just last week and joins Pfizer/BioNTech in securing UK, U.S. and EU approvals. So which developers are next in line for approvals?

AstraZeneca, whose vaccine was approved in the UK and India last week, hasn’t yet submitted an application to the FDA for an EUA, but it is expected to file in late January when it has new phase 3 efficacy results (DID, Dec. 4, 2020). The European Commission, which will receive the same data, is not expected to approve the AZ/Oxford University vaccine until February or later (DID, Dec. 30, 2020).

Moncef Slaoui, chief adviser to the Trump administration’s Operation Warp Speed, said he believes FDA approval of the AZ/Oxford vaccine won’t occur until early April (DID, Jan. 4). But Slaoui has expressed optimism that the single-dose J&J vaccine, JNJ-78436735, could be approved in the U.S. in February, based on phase 3 efficacy data expected later this month (DID, Dec. 11, 2020). The European Medicines Agency (EMA) is conducting a rolling review of the J&J vaccine and is expected to make a swift recommendation as soon as the new data are available.

Meanwhile, Novavax is playing catch up because of a vaccine supply problem that delayed the launch of a phase 3 trial. The company began a phase 3 study in the U.S. and Mexico at the end of December to evaluate its vaccine, NVX-CoV2373 (DID, Dec. 29, 2020). It also has an ongoing phase 3 study in the UK, a phase 2b study in South Africa and a phase 1 /2 trial in the U.S. and Australia. Novavax says it expects to have data available from those trials early this year.

Also trailing the field are Sanofi and GSK. The companies announced in December that they would delay a U.S. phase 2b trial of their co-developed vaccine candidate because it produced only a weak immune response in older adults (DID, Dec. 14, 2020) and predicted that their vaccine won’t be available until late in 2021 at the earliest.

Inovio’s vaccine candidate, INO-4800, is in an ongoing phase 2 trial in China, a phase 1/2a trial in South Korea and a phase 2/3 U.S. trial. However, the FDA has placed the phase 3 portion of the U.S. trial on partial clinical hold over safety concerns associated with the smart device used to administer the vaccine, dashing hopes for a swift approval by the agency (DID, Dec. 8, 2020). Early phase 1 data showed IN0-4800 induced immunity in all trial subjects, but the lack of data from a late-stage trial will mean a delay in filing for approval.

Merck, meanwhile, has two vaccine candidates still in phase 1 trials, V591, developed with France’s Institute Pasteur, and V590, developed with the International AIDS Vaccine Initiative (IAVI). For now, Merck is unsure when these trials will progress to phase 2, a company spokesperson told FDAnews. ― Jason Scott