Vaccine Makers Plan Public Stance to Counter Pressure on FDA (1)

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 multi-company statement as soon as next week. The plans, which could still change, were described by people involved in the effort on condition of anonymity.

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 seal of approval for its drugs and vaccines, assuring patients that the products are safe and effective. 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 in batting down the virus in the U.S. One recent poll found that a majority of the public thought a vaccine approval would be driven by politics.

Health officials inside the Trump administration 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.

At the same time, the president has accused the agency of slowing work to hurt him politically, and said he believes a vaccine will be ready before election day on Nov. 3.

Trump Push

At a news conference at the White House Friday, President Donald 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 Trump 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.

Others in the administration including Moncef Slaoui, the chief adviser for the Warp Speed program, have tamped down those expectations. Slaoui told National Public Radio 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 Officer David Ricks said that most companies in the industry wouldn’t submit a Covid-19 product to the FDA until they were confident in the science behind it. The company is developing a Covid-19 treatment, but isn’t among the companies that are 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 the 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 also 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 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.

(Updates with more details of vaccine effort starting in the fifth paragraph)

--With assistance from Drew Armstrong, Anna Edney and Riley Griffin.

To contact the reporter on this story:
Robert Langreth in New York at rlangreth@bloomberg.net

To contact the editor responsible for this story:
Drew Armstrong at darmstrong17@bloomberg.net

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