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Vaccine makers plan public stance to counter pressure on FDA

Clarety Kaseke, a research technician at the Ragon Institute, worked on non-COVID-19 cells while in the early stages of developing a vaccine for the coronavirus.Erin Clark/Globe Staff

Drugmakers are planning a public pledge to not send any COVID-19 vaccine to the FDA for review without extensive safety and efficacy data, according to people familiar with the effort.

The joint stance is seen as a bulwark against political pressure being applied on the Food and Drug Administration to get a vaccine out as soon as possible. It is likely to be announced in a multicompany statement as soon as next week.

The companies involved in the discussions include Pfizer Inc., Moderna Inc., Johnson & Johnson, GlaxoSmithKline Plc, Sanofi, and possibly others. All are developing vaccines for COVID-19.

The drug industry has long relied on the FDA as a gold-standard approval for its drugs. But in the middle of the pandemic, the agency has made several controversial decisions to allow emergency use of therapies without rock-solid evidence they work.


A vaccine, which will need to be taken by millions of healthy people, requires significant uptake to be effective. One recent poll found a majority of the public thought a vaccine approval would be driven by politics. Federal health officials have said the process will be based entirely on science, and FDA Commissioner Stephen Hahn has said he would not participate if he thought a vaccine were being rubber-stamped.

Meanwhile, President Trump has accused the FDA of slowing work to hurt him politically, and said he believes a vaccine will be ready before election day on Nov. 3.

At a news conference at the White House Friday, President Trump said a vaccine could be ready “maybe even before November first” or “some time in the month of October.”

“I think you’re going to see results that are shockingly good,” Trump said. It’s not clear what he was talking about, since results of trials are typically kept confidential while they’re ongoing, with occasional looks by a panel of experts to see if there are safety issues, or overwhelming signs a product is working or failing.


Much of the vaccine work is being done under the umbrella of the government’s Operation Warp Speed, which has struck deals with drugmakers to fund development and manufacturing. But the chief adviser for Warp Speed, Others in the administration, including Moncef Slaoui, the chief adviser for the Warp Speed program, have sought to tamp down those expectations, saying in a National Public Radio interview this week that it’s “extremely unlikely” a vaccine would be ready by election day.

In an interview with the news organization Axios this week, Eli Lilly & Co. Chief Executive David Ricks said drug companies wouldn’t submit a COVID-19 product to the FDA until they were confident in the science behind it. Eli Lilly is developing a COVID-19 treatment, but is not part of the vaccine effort.

“Most of the principals in our industry and their scientific teams would say we’re not going to make something or we’re not going to sell it until we’ve proven to our own standards it’s safe and effective, subjected it to scientific scrutiny from the outside world,” Ricks said.

Ricks is also head of the drug industry’s lobbying group, PhRMA.

Final-stage vaccine trials are rushing toward completion, and earlier this week Pfizer said it could have results by October. The FDA has set an Oct. 22 date for an outside group of experts to discuss a potential vaccine.


Others associated with the industry have urged a similar strict standard.

“I can say with complete authority that no company wants to have anything approved but under the strictest standards, the gold standard at the FDA,” said Jim Greenwood, the former head of the trade group BIO, the trade group representing biotechnology companies.

“It’s in no biopharmaceutical company’s interest to have a product provided to patients that isn’t proven to be completely safe and effective,” Greenwood said in an interview.