Washington: American pharmaceutical companies are planning to make a public pledge to not send any COVID-19 vaccine to the US Food and Drug Administration 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 FDA to release a vaccine 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 with the pledge on condition of anonymity.
The companies involved in the discussions include Pfizer, Moderna, Johnson & Johnson, GlaxoSmithKline, 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 that 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 US. 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 would 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, President Donald Trump has accused the agency of slowing work to hurt him politically, and said he believed a vaccine would be ready before election day on November 3.
At a news conference at the White House on Friday, 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 program, have tamped down those expectations. Slaoui told National Public Radio this week that it was “extremely unlikely” a vaccine would be ready by election day.
In an interview with the news organisation 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 treatment, but isn’t among the companies party to 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 October 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.
The head of the World Health Organisation said the UN health agency also would not recommend any COVID-19 vaccine before it was proven safe and effective, even as Russia and China have started using their experimental vaccines before large studies have finished and other countries have proposed streamlining authorisation procedures.
Last week, Britain said it was preparing to revise its laws so that any effective coronavirus vaccine could be used before it was fully licensed.
“I would like to assure the public that WHO will not endorse a vaccine that’s not effective and safe,” Dr Tedros Adhanom Ghebreyesus said.
Russia became the first country in the world to approve a COVID-19 vaccine in August after licensing a shot that had only been tested in about 40 people.
On Friday, Russian scientists published data suggesting their Sputnik V vaccine was safe and prompted an antibody response that would last “two years or more”, but the results were limited and experts said the shot had not yet been proven to work. The vaccine is now being tested in about 40,000 people and is offered to key workers like doctors and teachers. Among those who have received it are one of President Vladimir Putin’s daughters and Defence Minister Sergei Shoigu.
China has reportedly begun inoculating some high-risk groups with one of its experimental coronavirus vaccine while the large studies to prove its efficacy and safety are ongoing. In July, the head of China’s Centre for Disease Control and Prevention announced that he had received the shot, although he did not specify whether that was done as part of a clinical trial.