A volunteer receives the Covid-19 vaccine from Yaquelin De La Cruz at the Research Centers of America in Hollywood, Florida on August 13, 2020 (Photo by CHANDAN KHANNA / AFP).
To establish the degree of certainty of the vaccine’s effectiveness in the real world, an experiment requires tens of thousands of participants against the few hundred people that are needed in early-stage trials.
- News18.com
- Last update: September 3, 2020 2:23 PM IST
- Edited by: Ahona Sengupta
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In the race to produce a vaccine for the new coronavirus, drug manufacturers are currently absorbed in determining the effectiveness of the vaccine based on their first data and, at the same time, meeting the objective set by the sovereign governments in their respective countries. nations.
According to Airfinity Ltd., an analysis company that tracks drug trials, the first results to determine the effectiveness of a COVID-19 vaccine could come in mid-September from AstraZeneca Plc, which has committed to supplying 30 million doses to the UK by the end of the month.
On the other hand, Moderna Inc. of the United States and the American-German partnership of Pfizer Inc. and BioNTech SE may also present their research data ahead of a major Food and Drug Administration meeting on vaccines scheduled for 22 October, Airfinity said. . Meanwhile, Sinovac Biotech Ltd. of China, could have initial results soon after the meeting, the Livemint reported.
Preliminary results are known as interim readings, which are snapshots taken before the end of the study with only a fraction of the data. Previously, the World Health Organization warned countries not to approve a vaccine in a hurry before clarifying all its risks and benefits.
With the relentless spread of the coronavirus in Europe, India and the US, the preliminary figures may act as an early indicator.
“The first results should be enough to give us a very good idea of where we are going. They are moving faster than one could have anticipated, “said Airfinity CEO Rasmus Bech Hansen. Livemint.
Unlike drugs, the vaccines are given to relatively healthy people, and so far each of these experimental vaccines has shown promise in smaller trials designed to pinpoint any serious safety concerns and show whether the candidates can stimulate any responses. of the immune system. The report said.
However, to establish the degree of certainty of the vaccine’s effectiveness in the real world, an experiment requires tens of thousands of participants versus the few hundred people that are needed in early-stage trials.
The Airfinity projection said drug makers generally apply for regulatory approval after the final results of the trials arrive. “Overwhelmingly positive interim results could lead to studies being stopped early and vaccines being quickly released to the public,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Los Angeles Times earlier this week.
Airfinity studies are based on publicly available data on trial enrollment and design, along with infection rates at the sites where patients are enrolled.
Meanwhile, last month, a COVID-19 candidate vaccine jointly developed by pharmaceutical giant Pfizer and German biotech company BioNTech induces a “robust” immune response in healthy adults ages 18 to 55, according to an interim report from a initial phase. clinical trial, published in the journal Nature on Wednesday.
The researchers noted that BNT162b1 is an RNA vaccine that elicits an immune response by mimicking the mRNA molecule used by the novel SARS-CoV-2 coronavirus to build its infectious proteins.
Pfizer has also said it can collect enough data for authorization starting in October. With the company currently recruiting people for its 30,000-person trial, it will likely be the first American pharmacist with interim data in October. 15, but will not have full results until November 17.
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