Pfizer's COVID vaccine could be approved by Health Canada in January
- par Laura Grandis
- dans Médecine
- — Nov 19, 2020
All of the COVID-19 cases in the study were confirmed after people reported symptoms of infection; researchers then looked at those who were positive for COVID-19 and compared the vaccinated and placebo groups for whether they developed more symptoms of the disease.
Drugmaker Pfizer has provided updated analysis around its COVID-19 vaccine Phase 3 clinical trial data, saying that in the final result of its analysis of the 44,000-participant trial, its COVID-19 vaccine candidate proved 95% percent effective.
The data have not yet been published or peer reviewed, but will be closely scrutinized by the Food and Drug Administration and an independent advisory committee that makes recommendations to the agency. Such protection, however, is still important as the pandemic continues to sweep around the world and doctors have little ability to predict who will get more severely ill.
Pfizer's vaccine was 95 per cent effective and had no side effects in the Phase 3 study of nearly 44,000 volunteers that it and its partner BioNTech just completed, the company said. She said the results in people over 65 were the most promising.
USA company Moderna, which is using similar technology to Pfizer, has also announced promising early results for its vaccine candidate, though that testing is ongoing. The newly released data from Pfizer shows similar efficacy.
Both Pfizer and Moderna have said the accelerating pace of the pandemic has had the silver lining of speeding up their trials, since volunteers are becoming infected with the virus more quickly.
Pfizer said 170 volunteers in its trial involving over 43,000 people contracted COVID-19 but 162 of them had only been given a placebo, meaning the vaccine was 95% effective. The company also reported that 9 out of 10 of the severe cases among those who were infected occurred in the placebo group, suggesting that even in the rare occasion that the vaccine didn't prevent contraction of COVID-19, it helped reduce its severity.
"This group is amongst those most at risk of serious illness, and alongside healthcare workers must be prioritised to receive the first doses of any vaccines". The findings Pfizer announced on Wednesday haven't yet been submitted to Health Canada for review. The only adverse event, noted in more than two per cent of people, was fatigue (3.8 per cent) and headache (two per cent).
Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future. "Our significant issues, with respect to the Pfizer vaccine in particular, it needs to be stored at - 75 C and Moderna at - 20 C". All three are among the seven vaccine candidates Canada has contracts to buy on the understanding the doses will only be delivered if Health Canada green-lights the vaccine.
During question period at Queen's Park on Wednesday, Elliott said that her government is expecting to receive 1.6 million doses of the Pfizer vaccine and 800,000 doses of the Moderna vaccine in January, February and March of 2021.
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