Pharma Companies to Release Pledge Promising Not to Seek Federal Approval Until Vaccine Is Safe

A nurse in Brazil holds a coronavirus vaccine candidate made by the Chinese company Sinovac Biotech. The trial for the vaccine is being carried out in Brazil. (Photo: Silvio Avila / AFP, Getty Images)
A nurse in Brazil holds a COVID-19 vaccine candidate made by the Chinese company Sinovac Biotech. The trial for the vaccine is being carried out in Brazil. (Photo: Silvio Avila / AFP, Getty Images)

Pharmaceutical companies are aiming to assuage the public’s anxiety, ever inflamed by a selfish U.S. president, over the safety of coronavirus vaccines. To calm fears, big-name drug makers like Pfizer, Johnson & Johnson and Moderna will sign a joint statement to demonstrate their commitment to safety and effectiveness.

The pledge, which was reported and reviewed by the Wall Street Journal, could be released as early as next week. Per the Journal, the statement affirms that the manufacturers’ priority will be the safety and well-being of vaccinated people. In addition, the pledge states that the companies would also commit to following high scientific and ethical standards when carrying out clinical studies and during the manufacturing process.

“We believe this pledge will help ensure public confidence in the Covid-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated,” the pharmaceutical companies said in the draft statement, according to the Journal.

In addition, the New York Times reports that drug makers GlaxoSmithKline and Sanofi have also signed the pledge.

The companies will purportedly pledge not to seek government approval until the vaccines have been proven safe and effective. The Journal reports that the draft statement said they would submit applications for government emergency use authorization or licensure of vaccines based on “substantial evidence of safety and efficacy” from Phase 3 clinical trials conducted under guidance from the Food and Drug Administration.

Before getting to Phase 3, a vaccine candidate must pass through several other phases. As explained in the New York Times Coronavirus Vaccine Tracker, the first step is preclinical testing, in which the new vaccine is tested on cells and animals. Next come Phase 1 trials, which are given to a small number of people and study safety and dosage. Phase 2 trials are carried out with hundreds of people and further test the vaccine’s safety and ability to stimulate the immune system.

Finally, Phase 3 trials are given to thousands of people. Scientists then wait to see how many of the people that were given the vaccine become infected compared to those who received a placebo. Phase 3 trials are typically the last stage of clinical research needed before a treatment or drug receives government approval.

In June, the FDA said a vaccine for covid-19, the disease caused by the novel coronavirus, would need to prevent or decrease the severity of the disease in at least 50% of the people vaccinated.

Americans have been expressing wariness over a future coronavirus vaccine for months. Only half of Americans said they planned to get vaccinated if one is developed, according to a May poll conducted by the Associated Press and the NORC Centre for Public Affairs Research.

Reports that President Donald Trump is exploring ways to release an experimental coronavirus vaccine before the November election in a blatant attempt to improve his reelection prospects even if the vaccine doesn’t meet FDA safety standards probably haven’t helped, either.

In an interview released by CNN on Saturday, Democratic vice presidential nominee Kamala Harris said that she would not trust the president’s word alone when it comes to a coronavirus vaccine.

“I will say that I would not trust Donald Trump and it would have to be a credible source of information that talks about the efficacy and the reliability of whatever he’s talking about,” Harris said. “I will not take his word for it.”

[The Wall Street Journal]