Pfizer, a multinational pharmaceutical corporation and one the largest worldwide, announced on November 9th that the data on their coronavirus vaccine (to date), shows the potential of being 90% effective. A very important and encouraging development in the race to find a vaccine that could help in the global effort to protect as many as possible from being infected with the Covid-19 virus. Pfizer has collaborated with Germany’s BioNTech and they are working on one of 10 potential vaccines around the world in late-stage testing. Even if all goes well, the vaccine is not expected to be ready until the end of the year at the earliest and supplies will be rationed.
Prime Minister Justin Trudeau said a news conference that Canada has signed a deal with Pfizer ‘to secure millions doses of the possible vaccine’ and it is ‘one of a broad range of candidates’ they have secured access to should they prove to be successful. He said ‘the results were very promising’ but that ‘distribution will be challenging’. In order for the vaccine to remain stable it has to be stored at a specific temperature and Trudeau said it will ‘require some very careful cooperation from provinces and supply chains for it to get out to Canadians on a priority basis’ and that ‘we are already working on those necessary logistical supports’.
Explaining how the potential vaccine is being tested, Pfizer’s senior vice-president of clinical development, Dr. Bill Gruber, told The Associated Press that ‘Volunteers in the final-stage studies and the researchers do not know who received the real vaccine or a dummy shot’. However, a week after their second required dose, Pfizer’s study began counting the number of those who developed COVID-19 symptoms and were confirmed to have the coronavirus. Because the study has not ended, Gruber could not say how many in each group had infections. Pfizer does not plan to stop its study until it records 164 infections among all the volunteers, a number that the FDA has agreed is enough to tell how well the vaccine is working. The agency has made it clear that any vaccine must be at least 50% effective.
Dr.Gruber said that so far, no participant has become severely ill, but he could not offer a breakdown of how many of the infections had occurred in older people, who are at a higher risk from COVID-19. Because participants were only tested if they developed symptoms, it left the question unanswered on whether vaccinated people could be infected but show no symptoms and unknowingly spread the virus. According to the FDA, companies working on a vaccine must track half their participants for side effects for at least two months, a recognized time period for any problems to show up. Pfizer expects to reach that milestone by the end of this month, but said that so far no serious safety concerns have been reported.
Due to the continued and disconcerting spread of the pandemic, manufacturers are hoping to get permission from governments for emergency use of their vaccines, while additional testing continues. It would allow them to get the vaccines out there faster than normal, but still raise concerns about how much will be known about them. The US FDA’s scientific advisers recently said they ‘worry that allowing emergency use of a COVID-19 vaccine could damage confidence in the shots and make it harder to ever find out how well they really work’ and that ‘it’s critical these massive studies are allowed to run to completion’. Pfizer said its data would be peer reviewed, once it has results from the entire trial.
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