Despite an increasingly urgent timeline for developing a COVID-19 vaccine, CEOs of nine major drug companies signed a letter promising not to sacrifice safety for speed.
The COVID-19 vaccination pledge follows news that last week the Centers for Disease Control and Prevention (CDC) alerted local and state health officials across the country that they must be ready to offer a COVID-19 vaccine for certain groups to be provided by the beginning of November New York Times reported. In particular, local health departments should be ready to distribute the vaccine to health workers and to people in some risk groups.
The documents were sent the same day that President Trump said in his speech at the Republican National Convention that a vaccine could be available by the end of the year. And in early August, the president said he was optimistic that a vaccine would be ready “around”
Now, the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi have signed a pledge that they will make the “safety and well-being of vaccinated individuals our top priority” while adhering to scientific and ethical standards for the testing and production of a vaccine and for maintaining an adequate supply and selection of vaccines.
The promise also states that these companies will not seek approval or emergency approval from the Food and Drug Administration (FDA) until the vaccine meets safety and efficacy standards of a Phase 3 clinical trial that meets the standards required for the Admission should meet. AstraZeneca and Moderna each have a vaccine that is already in phase 3, SELF previously reported. BioNTech and Pfizer have a joint vaccine, which is also currently in phase 3.
After criticism that the preliminary experiment was too white, Moderna announced last week that it would slow progress on vaccine trials to ensure racial diversity among participants. This is a particularly important step given the historic lack of diversity in clinical trials and the disproportionate impact COVID-19 has had on color communities.
While it would be great to have a safe and effective COVID-19 vaccine within a few months, some experts fear the schedule would be too fast. Last month, Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases Reuters that it would be a bad idea to get vaccine approval or emergency clearance “before you have a signal of effectiveness”. And experts previously told SELF that an early November deadline “seems tight,” noting that testing for many of the current vaccine candidates will continue for the next year or two.
For one thing, it would be difficult to get people to sign up for studies with other vaccines, said Dr. Fauci. However, if you get a vaccine approved or approved without showing that it is both safe and effective, it may mean that it may not be as effective against COVID-19 as we would like it to be, and possibly people for that Susceptible to infection. And in the worst case scenario, there could be unforeseen vaccine side effects that weren’t caught because the tests weren’t as thorough as they should have been.
While it is a little wild that this is necessary, the COVID-19 vaccination pledge is meant to assure us that every vaccine that becomes available has passed rigorous testing standards before being made public – even if that means one political vaccine is missing. driven deadline. However, if we are battling a pandemic at a time when procrastinating about the vaccine is already a threat to public health, it is more important than ever to ensure that the public feels as safe as possible about getting a coronavirus vaccine – whenever possible.