Covid-19 vaccine update: Trials of Sputnik V likely to resume in India, Pfizer says US could have vaccine by November

  October 17, 2020

New Delhi, October 17 : US pharma giant Pfizer, which is developing a potential coronavirus vaccine with BioNTech, has said it could have the vaccine in November. Pfizer Inc has announced that it could apply for US authorisation of the vaccine by November.

Meanwhile, the Russian coronavirus vaccine (Sputnik V) that suffered a setback in India, may again resume the clinical trials being conducted by Dr Reddy’s/

There are over 150 coronavirus vaccine candidates in the global race with about 10 of them in the Phase III clinical trials. Some of the top contenders that are being awaited with high anticipation are the Pfizer vaccine, Oxford and AstraZeneca’s coronavirus vaccine, Johnson & Johnson vaccine, Moderna and China’s Sinovac among others.

PFIZER VACCINE BY NOVEMBER?

Pfizer has announced that it could apply for US authorization for the coronavirus vaccine it is developing with German partner BioNTech in November. The announcement has raised hopes of having a coronavirus vaccine as early as November. Soon after the statement, Pfizer’s stocks gained by 3.4% in the markets.

While Pfizer has made the announcement, it has also said that the researchers are awaiting the safety data from 44,000 people who took part in the clinical trials and those will not be available until next month. US President Donald Trump, who is seeking re-election in the November polls, had promised a coronavirus vaccine in the United States by next month.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said on Friday.

VACCINE IN INDIA BY MARCH?

The Serum Institute of India (SII), which is manufacturing the coronavirus vaccine being developed by Oxford University and AstraZeneca, is hoping that if regulators give the green signal, India could have a vaccine by March next year.

Two coronavirus vaccine candidates are in advanced trial stages in India and SII executive director Dr Suresh Jadhav has told The Indian Express that country could have a vaccine by March if all drug regulators give the green signal.

Jadhav believes with multiple drugmakers working on the job, India is all set to have a coronavirus vaccine early next year. Apart from the Oxford-AstraZeneca coronavirus vaccine, India’s own Bharat Biotech, which is developing the Covaxin, is also in Phase III clinical trials.

Dr REDDY’S TO GET NOD FOR INDIA TRIALS

After the Indian drug regulator put a stop on Dr Reddy’s Laboratories conducting clinical trials for the Russian coronavirus vaccine Sputnik V, sources have told PTI that the panel has now recommended granting permission to the lab to go ahead with the testing.

The Hyderabad-based pharmaceutical firm had on October 13 reapplied to the Drugs Controller General of India (DCGI) seeking permission to conduct combined Phase II and Phase III human clinical trials of the Russian vaccine in India.

In its revised protocol, the firm stated that the Phase II trial would include 100 subjects, while the Phase III trials would involve 1,400 volunteers, reported PTI. The subject expert committee (SEC) on Covid-19 deliberated on the application on Friday.

The SEC had on October 5 asked Dr Reddy’s to re-apply stating it will have to conduct both Phase II and Phase III clinical trials and cannot directly hold Phase III trial for the Covid-19 vaccine in India.

BRITAIN MAY INFECT VOLUNTEERS WITH COVID-19

A Britain biotech firm has said a vaccine clinical trial in which volunteers are deliberately infected with Covid-19 could become a reality and that it was in advanced talks with the government for permission.

Preliminary work for the trials, which aim to speed up the process of determining the efficacy of a vaccine candidate, is being carried out by hVIVO, a unit of pharmaceutical services company Open Orphan, hVIVO said on Friday.

If agreed, this would involve creating a human challenge study model that could be used should such trials gain ethical and safety approval from regulators, reported Reuters.

Supporters of human challenge trials say they are a good way to cut short the often lengthy process of testing potential vaccines on tens of thousands of volunteers in the real world who go about normal life and are monitored to see if they contract the disease or are protected from it.

WHO ON RUSSIAN VACCINE

Russia has already approved its second coronavirus vaccine candidate and the World Health Organisation (WHO) said on Friday that it has had a “good dialogue” with the developers of the new vaccine. “We will only be able to have a position on a vaccine when we see results of the Phase III clinical trials,” WHO Chief Scientist Soumya Swaminathan told a news conference in Geneva.

CHINA’S SINOVAC VACCINE ON SALE

China’s Sinovac Biotech is still in Phase III trials of its coronavirus vaccine candidate and even before the results could be analysed a Chinese city has started offering the vaccine to essential workers and other high-risk groups at a price of $60.

The Chinese city of Jiaxin’s center for disease control and prevention (CDC) said in a statement on WeChat that two doses of the vaccine candidate, called CoronaVac, will cost 200 yuan ($29.75) per dose and that vaccinations for key groups including medical professionals have begun.

According to Reuters, Sinovac did not immediately respond to a request for comment. Its vaccine is in late stage trials in Brazil, Indonesia and Turkey, and the company has said that an interim analysis of Phase III trial data could come as early as November.

(With inputs from PTI and Reuters/India Today)

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