Without explaining its reasons, the FDA has not yet signaled that AstraZeneca’s interrupted US trial can be resumed, as it has been in all other jurisdictions. The Anglo-Swedish pharma has now confirmed the diagnosis but it is not yet clear what caused the female patient’s transverse myelitis.

In a letter leaked to Bloomberg Law, more than 60 medical professionals, including “leading researchers and bioethicists,” called on US drugmaker Pfizer and its German development partner BioNTech to wait at least late November before seeking FDA authorization of its mRNA-based vaccine. Before that, it should not consider granting an Emergency Use Authorization (EUA).

Pifzer said on Sept. 25 that it expected to publish results of its own Phase 3 trial before the end of October, which could put it ahead of both AstraZeneca and US biotech Moderna. Following this, the drugmaker said it would file for approval, without naming a date.

In the letter, received by Bloomberg on the same date, the researchers said Pfizer’s clinical trial should monitor participants for at least two months after they received the second dose. To be successful, they said, the public needs to have the utmost trust in the vaccine and the science behind it.

“Submission of an EUA application on a shorter timetable would “severely erode public trust and set back efforts to achieve widespread vaccination,” the letter writers said, adding that, “a premature application would prolong the pandemic, with disastrous consequences.

Bloomberg said it had verified six of the signatories and named three of them. The list included Joshua M. Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins University and a former second-in-command at the FDA, along with Esther K. Choo, an emergency medicine physician and professor at Oregon Health & Science University, and Jeffrey R. Botkin, a University of Utah professor of pediatrics and medical ethics.

While the letter did not broach the issue of political interference, many Americans are seen as increasingly skeptical of speed in vaccine development. Recent polls showed that more than a third of those questioned would be willing to take the first available vaccine. Moreover, they said they were concerned about a possible coincidence of the election date and the release of the first vaccine.

As of Sept. 28, Pfizer’s phase 3 trial had enrolled more than 35,000 participants, and more than 24,000 had received their second doses. Altogether 44,000 people are planned to be enrolled in this study.

A Pfizer spokeswoman told US media the drugmaker “is “very appreciative” of the experts’ input, and that it is “committed to providing sufficient efficacy and safety data to help FDA determine the best regulatory mechanism for making the vaccine available to the public.

“We anticipate providing FDA with safety data, including the median of two months safety data after the second dose, on a rolling basis,” she added, while promising that the company “will track safety and outcomes data for two years during the trial.”

Operation Warp Speed, the Trump aministration’s well-funded vaccine task force, has announced the goal of developing, producing and distributing 300 million doses of a Covid vaccine by January 2021, though the president continues to press for earlier delivery.

Paul Mango, deputy chief of staff for policy at the US Department of Health and Human Services (HHS), told the trade journal Stat that the military is heavily involved in the project. Among other things, it has set up “significant cybersecurity and physical security operations to ensure an eventual vaccine is guarded very closely from ‘state actors’ who don’t want us to be successful in this.”

Mango said also that that many of the Warp Speed discussions take place in protected rooms used to discuss classified information.

Author: Dede Williams, Freelance Journalist