Politico

Vaccine makers promise safety amid shaky public confidence in Covid developments


Nine pharmaceutical companies developing coronavirus vaccines issued an unusual joint pledge Tuesday to stick to safety and science amid mounting public fears that pre-election politics could drive vaccine decisions.

Each of the drugmakers has moved a vaccine into clinical trials in record time. But public confidence in the shots has dropped as President Donald Trump has repeatedly predicted that a vaccine could come before the Nov. 3 election. Nearly a fifth of Americans are hesitant to take a Covid-19 vaccine and just 14 percent would be more likely to take one that Trump recommended, a July POLITICO/Morning Consult survey found.

Executives for the nine manufacturers promised to only submit potential Covid-19 vaccines for approval or emergency use authorization after demonstrating safety and efficacy through a Phase III trial, the final and sweeping study, that meets Food and Drug Administration requirements. Three are currently undergoing Phase III testing.

“I’m disappointed,” said Rachel Sachs, an associate professor of law at Washington University in St. Louis who studies food and drug regulation. “There’s zero mention in this pledge about transparency.” A promise from vaccine developers to be transparent about clinical trial results and data is crucial because of growing distrust of the government’s statements on vaccine safety and efficacy, she added.

Drugmakers have to submit their own products for approval. But HHS’s assistant secretary for preparedness and response can request the FDA grant emergency authorization for certain products — a lower threshold than full FDA approval. It’s that emergency scenario that has spurred fears that a vaccine could be rushed out before the election for political reasons.

Trump said again over the Labor Day weekend that a vaccine would probably be available in October, just ahead of the election and before any of those Phase III trials are complete, contradicting health experts in and out of government who have said repeatedly that late 2020 or early 2021 is a more realistic timeframe.

“We’ll have the vaccine soon, maybe before a special date. You know what date I’m talking about,” he said at a news conference Monday.

The president’s insistence that a vaccine is possible before the election has become a campaign issue for Democrats. On Saturday, Democratic vice-presidential candidate Kamala Harris said that she “would not trust Donald Trump” on the reliability of a vaccine — prompting the president to lash out and accuse Harris of sabotaging a prospective vaccine for political ends.

In their joint pledge, executives of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi committed to putting safety first, continuing an ethical clinical trial process and working to ensure enough vaccine supplies and options for global access.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” the companies said in the pledge.

The vaccine makers’ statement follows an open letter on Thursday from biotech industry trade group BIO that calls for all vaccine developers to follow a rigorous scientific process.

Three vaccine candidates, from AstraZeneca, Moderna and Pfizer/BioNTech, have entered Phase III trials. Pfizer CEO Albert Bourla said Thursday that the company will know if its coronavirus vaccine works by the end of October. But it would still need to be submitted for emergency use or full FDA approval.

In a statement Tuesday, Pfizer said it could seek regulatory review as early as October “if — and only if — the pivotal clinical trial proves out vaccine candidate to be safe, effective, and in line with the FDA’s guidance. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial.”

The head of the government’s vaccine accelerator has said that the October timeframe may be too ambitious for most vaccines now in late-stage trials.

“There is a very, very low chance that the trials that are running as we speak could read before the end of October,” Moncef Slaoui, who heads the government’s Operation Warp Speed effort, told NPR last week. “I think it’s extremely unlikely but not impossible, and therefore it’s the right thing to do to be prepared in case.”

FDA Commissioner Stephen Hahn has also denied politics would play any role in their decisions and the agency has set up a public meeting for an advisory committee of vaccine experts on October 22.

Zachary Brennan contributed to this report.

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