Astrazeneca, and all the other companies under Food and Drug Administration purview, are developing vaccines for COVID-19. In the midst of current trials across the globe, they paused operation when a participant in the United Kingdom developed symptoms of a spinal inflammatory disease. While this pause is an encouraging sign of ethical standards being upheld, why is there not more transparency in these trials and in vaccine approval in general?
Details for the hold on trials by AstraZeneca have not been fully disclosed and internal discussions are not publicized. It is encouraging to see that they paused trials for the safety of a patient, yet the lack of transparency by the drug company is cause for caution. This vaccine is meant to save lives and return the world to normalcy, but the public is not allowed to know about the daily advancements of the drug? People ought to know more about the safety event in question.
This is not to say reveal the identities of the participants. This is simply a request to know more about the trials, about the decision to stop the trials after the participant developed symptoms, about the decision to restart trials a week later in the UK and Brazil, but not in the United States, South Africa, or India, etc.
National Institute of Health official Dr. Avindra Nath commented that AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people…we would like to see how we can help, but the lack of information makes it difficult to do so.”
Dr. Jesse Goodman, a Georgetown University professor and former Chief Scientist at the FDA said that the FDA must consult with British vaccine regulators to understand why they resumed trials. He further commented that AstraZeneca must be required to update safety information provided to the participants.These trials must be more transparent in their development of a drug that will be administered to millions.
Why stop at transparency in individual trials? The public deserves to know more about the vaccines being approved in the coming months. What are the vaccine requirements for emergency use authorization approval in the US? There is already evidence suggesting that the Food and Drug Administration has issued EUAs for therapies like hydroxychloroquine and convalescent serum without substantial research that they work.
How many patients does a successful study need to have for an approved vaccine? Three hundred? Three thousand? Some experts recommend that the number be thirty thousand or more. That is only to get a vaccine approved. The FDA must require further controlled study once an EUA is granted. Phase four of typical clinical trials involves thousands of participants monitored in what is called a postmarketing surveillance trial. In short, drug companies monitor their released drugs to ensure they are working.
Another transparency concern is the threshold of success a vaccine needs to have. The FDA has stated that a vaccine needs to prevent or reduce disease in a participant group by fifty percent. First, what happens to the other fifty percent? A successful vaccine should have a much higher hit rate. Second, what if a vaccine has a reduction rate of forty percent or even thirty percent? It is not too farfetched to suggest the FDA would take that number as a close enough figure.
There are two related dangers with premature EUAs. First, a premature EUA granted to a vaccine may seriously compromise the integrity of future vaccine trials. Control groups are integral to the testing process. Though as we have seen with hydroxychloroquine and convalescent serum, participants may believe that it is their right to be given the actual vaccine in trials.
Second, once a vaccine is granted authorization, many people will take that as a sign that the dangers of COVID-19 are over. This is far from the case, as it takes many months or even several years until we know the safety of a vaccine. Systems for administration have to be perfected. There is also a belief that once a vaccine is available, many will modify their behavior in a way that could seriously exacerbate the pandemic. Recent data suggests premature relaxation of habits can double or more infection rates, as we’ve seen in the US and abroad in recent months.
Then there are the issues concerning long term protections and dangers. There have been cases of reinfection both in the US and abroad. Were reinfection to become a major issue as temperatures drop and people return indoors, the question of whether a new vaccine to cover reinfections for the future. There is also plenty of evidence of antibody dependent facilitation of reinfection, or reinfection with worse symptoms due to the presence of antibodies, such as with common cold causing viruses.
This goes without mentioning the dangers of taking an undertested vaccine. Typically vaccines take years to ensure long term safety protections. It seems that a COVID-19 will be available by the end of the year, so any chance of understanding long term health risks will be out the window. The dangers to the public for taking an unproven and undertested vaccine are overwhelming. The opaque veil of vaccine approval must be lifted during this time of crisis. It is in the long term interest of the public to understand the process that has such a massive effect on their lives.