The companies will be filing for emergency approval from the US drug regulator which means the shots could be available for distribution as early as by the end of this year.
Pfizer Inc on November 18 said its COVID-19 vaccine with partner BioNTech SE was 95 percent effective in the final analysis based on clinical trials data. The companies are all set to seek emergency authorisation for use of the shots from regulators.
The company said the COVID-19 vaccine is showing signs of being safe for people across all ages and ethnicities and that no significant problems have been registered so far in the nearly 44,000 participants.
According to a Wall Street Journal report, Pfizer plans to seek approval for the vaccine’s use within days. This will mean the COVID vaccine could be available for distribution by year-end.
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
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Out of 170 adult volunteers, in the nearly 44,000-subject trial who developed Covid-19 with at least one symptom, 162 received a placebo, while eight got the vaccine, Pfizer and BioNTech said.
This 95 percent effectiveness rate brings the experimental candidate on par with the likes of shingles and measles vaccines.
As per the companies, the researchers did not find any serious safety issues. The vaccine appeared to be well tolerated following a review of data from 8,000 study subjects, it added.
The companies said they have collected the two months of safety data on about 19,000 study subjects requested by the US Food and Drug Administration. However, the firms are still in the process of reviewing all these results.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Pfizer Chief Executive Albert Bourla said. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” the report said.
Another candidate being developed by Moderna Inc was also found to be 94.5 percent effective in preventing COVID-19 based on interim data from a late-stage clinical trial.