Moncef Slaoui Says Efficacy Data for Pfizer, Moderna Vaccines Likely in Next Two Months

Even President Trump’s top COVID-19 advisers are starting to scale back their timelines for when a vaccine would be ready for Emergency Use Authorization (EUA) or approval despite the president’s assertions to the contrary.

The chief adviser for Operation Warp Speed, Moncef Slaoui, said this week that efficacy data for late-stage trials of COVID-19 vaccines is expected to roll out over the next couple months, with data for Pfizer’s and Moderna’s prominent vaccine candidates expected between November and December.

“We expect [Pfizer and Moderna] to read out, or have a first look, at their efficacy outcome within the next seven weeks. Nobody can really say when, but the expectation would be that this would happen between the month of November and December,” Slaoui said during a vaccine symposium.

Slaoui’s prediction clashes with the timeline presented by Pfizer CEO Albert Bourla, who said the company is on track to meeting its goal of having vaccine data ready for an EUA submission by October.

It remains to be seen if Pfizer will be able to file for an EUA by the end of the month. The European Medicines Agency (EMA) this week began a rolling review of the company’s vaccine candidate, BNT162b2,  citing encouraging results from preclinical and early clinical studies in adults (DID, Oct. 7).

The Warp Speed leader noted that the two companies have nearly completed recruiting patients for their massive late-stage vaccine trials, which are enrolling tens of thousands of participants. In Moderna’s case, it is enrolling around 50,000 subjects, while Pfizer is enrolling approximately 45,000.

AstraZeneca’s (AZ) and Johnson & Johnson’s vaccine candidates are also in late-stage trials, he noted, though the trials haven’t advanced as far in patient recruitment as Pfizer or Moderna. AZ’s trial remains on hold in the U.S. over a safety issue that triggered a review, but it has resumed in other countries, including in the UK and Japan (DID, Sept. 17). Efficacy data for those vaccine candidates isn’t expected until early next year.

“Because their recruitment is at an earlier stage, the expected earliest readout for efficacy of these vaccine trials is somewhere [in] 2021, probably January,” he said.

Vaccine candidates from Novavax and Sanofi/GSK are currently in phase 1 and phase 2 trials, with late-stage trials expected to start up in late November and produce efficacy data around March 2021, Slaoui said. — James Miessler