Nine pharmaceutical companies jointly agreed on Tuesday to “stand with science” and not propose a vaccine until it was thoroughly tested for safety and effectiveness.
The companies did not rule out applying for emergency approval for their vaccines, but promised that a potential coronavirus vaccine would be decided on the basis of "large, high-quality clinical trials" and that the companies would follow instructions from regulatory agencies such as the Food and Drug Administration consequences .
"We believe this promise will help build public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and ultimately approved," the companies said.
President Trump has repeatedly claimed over the past few weeks that a vaccine could be available before Election Day [November 3rd]. This adds to fears that his government is politicizing the race to develop a vaccine and possibly undermining public confidence in an approved vaccine.
"We will have the vaccine soon, maybe before a special date," the president said on Monday. "You know what date I'm talking about."
The move was welcomed by some researchers, who said the statement could increase public confidence in a coronavirus vaccine at a time when skepticism was high. "There is absolutely an urgent need for this vaccine," said Dr. Judith Feinberg, vice chairwoman of medical research at West Virginia University in Morgantown. "I love the fact that the top nine vaccine manufacturers today said they weren't going to do anything premature – I think there is tremendous pressure to do something premature."
Three of the companies that have signed the pledge are testing their vaccine candidates in late-stage clinical trials in the US: Pfizer, Moderna, and AstraZeneca.
Pfizer has stated repeatedly over the past week that this is for the F.D.A. for the emergency permit in October. On Tuesday its managing director, Dr. Albert Bourla, in an interview on NBC's "Today" broadcast, predicted that the company would have an answer on whether its vaccine would work by the end of October, but admitted that it would not mean its vaccine would be available to the public by then accessible.
Moderna and AstraZeneca were less specific, just saying they hope to have a vaccine by the end of the year. Last week, Moderna's executive director said the company slightly slowed its registration to include more people from groups hardest hit by Covid-19.
Pfizer and Moderna are close to fully enrolling the 30,000 participants in each of their studies. Some analysts predict it will be ready in the next two weeks. AstraZeneca is further behind in its US studies after enrollment began on August 31.
Federal officials have resisted Mr. Trump's enthusiastic predictions. Late last week, Moncef Slaoui, the top scientist at Operation Warp Speed, a federal attempt to get a vaccine to market quickly, warned in an interview with National Public Radio that the chance of successful vaccination results by October was "very, very slim" be. ”
And on Tuesday, Dr. Anthony S. Fauci, the nation's leading infectious disease expert, said the researchers would know if Moderna and Pfizer vaccines are effective by "November or December".
In a statement on Tuesday, Dr. Slaoui, the goal of Operation Warp Speed is "to ensure that no technical, logistical, or financial hurdles hinder the development or use of vaccines without limiting the critical steps required to establish solid scientific and regulatory standards." He added that the pledge "reaffirms Operation Warp Speed's position that this project is science-driven and that any vaccine must meet the Food and Drug Administration's gold standard."
Pharmaceutical companies had to carefully steer the political landscape. A successful vaccine could help restore the industry's image and end the pandemic. But when a vaccine is released that causes serious side effects – or just doesn't work – it can damage their reputation catastrophically.
In Tuesday's statement by the nine companies, Trump was not mentioned, but merely stated that they "have a shared commitment to uphold the integrity of the scientific process".
The other six companies that signed the pledge were BioNTech, which is developing the vaccine in collaboration with Pfizer, GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi.