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Covid-19 Vaccine Early Data Expected by September 15, But How Effective Will a Shot be?

A volunteer receives a Covid-19 vaccination from Yaquelin De La Cruz at the Research Centers of America in Hollywood, Florida, on August 13, 2020. (Photo by CHANDAN KHANNA/AFP)

A volunteer receives a Covid-19 vaccination 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 needed in early-stage trials.

In the race to produce a vaccine for the novel coronavirus, drugmakers are at present engrossed in determining the effectiveness of the vaccine based on its early data, and at the same time, meet the target set by the sovereign governments in their respective nations.

According to Airfinity Ltd., an analytics company that tracks drug trials, the first results to determine the effectiveness of a COVID-19 vaccine could come by mid-September from AstraZeneca Plc, which has promised to supply 30 million doses to the United Kingdom by the end of the month.

On the other hand, the United State’s Moderna Inc. and the US-German partnership of Pfizer Inc. and BioNTech SE may also come up with their research data ahead of an important Food and Drug Administration meeting on vaccines scheduled for October 22, Airfinity said. Meanwhile, China’s Sinovac Biotech Ltd., could have initial results shortly after the meeting, the Livemint reported.

The preliminary results are known as interim readouts, which are snapshots taken before the completion of the study with only a fraction of the data. Earlier, the World Health Organization warned countries against approving a vaccine in a hurry before gaining clarity on its full risks and benefits.

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With the relentless spread of the coronavirus in Europe, India and the US, the preliminary numbers may act as an early indicator.

“The first results should be enough to give us a very good idea of where we’re heading. They are moving faster than one could have anticipated," Airfinity Chief Executive Officer Rasmus Bech Hansen told Livemint.

Unlike drugs, vaccines are administered on relatively healthy people and so far, each of these experimental vaccines has shown promise in smaller trials designed to flag any serious safety concerns and show whether candidates can spur some response from the immune system. The report said.

However, to establish 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 needed in early-stage trials.

The Airfinity projection said that drugmakers usually request regulatory approval after the arrival of the final results of the trials. “Overwhelmingly positive interim results could lead to studies being stopped early and the vaccines being rushed to the public,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told the Los Angeles Times earlier this week.

Airfinity’s studies are based on publicly available data on trial enrollment and design, together with infection rates in places where patients are enrolled.

Meanwhile, last month, a COVID-19 vaccine candidate co-developed by the pharmaceutical giant Pfizer and the German biotech company BioNTech induces a “robust" immune response in healthy adults aged 18-55 years, according to an interim report of an early 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 coronavirus SARS-CoV-2 to build its infectious proteins.

Pfizer has also said that it can garner enough data for authorisation as early as October. With the company currently recruiting people for its 30,000-person trial, it will probably be the first US drugmaker with interim data by October. 15, but won’t have full results until November 17.

first published:September 03, 2020, 14:19 IST