Expert panel defers decision on early approval for vaccine

Independent vaccine experts advising Indian drug regulator on Wednesday deferred a decision to give accelerated approval to any of the Covid-19 vaccine candidates even as two firms, which applied for Emergency Use Authorisation made presentation before the panel.

Though three firms — the US headquartered MNC Pfizer; Pune-based Serum Institute of India (SII) making AstraZeneca-Oxford University vaccine, and the Hyderabad-based Bharat Biotech India Ltd (BBIL) — have applied for early approval for their vaccine candidates to the Drug Controller General of India (DCGI), only the two Indian firms presented their data before the Subject Expert Committee (SEC) appointed by the regulator. Pfizer may present its data at a later date.

The development came a day after an interim analysis published in the prestigious medical journal Lancet of the AstraZeneca-Oxford University vaccine, being manufactured in India by SII, was shown to be safe and effective. AstraZeneca officials said they have started applying for an early approval for their vaccine in many countries.

Review still on

Sources in the know of the development confirmed the presentations made by the two firms and said the review is still on and the companies may be asked for more data. The predicament of the experts is also understandable. In all three cases, there are large data gaps. While BBIL’s Covaxin is still undergoing Phase-III trials, SII, though has completed Phase-II/III trials, does not have the efficacy data. Pfizer may have efficacy data, but that comes from another country not from India.

However, the New Drug and Clinical Trials Rules 2019 give the drug regulator the power to approve a drug or vaccine for use in special situations by relaxing, abbreviating, omitting or deferring data.

Currently, the mRNA vaccine of Pfizer is the only Covid-19 antidote to get emergency use authorisation anywhere in the world — in the UK, which has strted to use, and subsequently in Bahrain.

The sources also said the Subject Expert Committee may have yet another meeting soon even though the date is not known at present. One of the companies also confirmed that it has not heard from the regulator whether its vaccine has been rejected or approved.

Questions on SII vaccine

Meanwhile, public health activists posed many questions about the SII vaccine for which data is available from just 1,600 peple in the country. In a letter written to DCGI and Health Secretary Rajesh Bhusan and Niti Aayog Member (Health) Vinod K Paul, the All India Drug Action Network asked whether India plans to consider the vaccine for accelerated approval ahead of Medicines and Health Care Products Regualtory Agency of the UK, where it completed most of the trials.

It also wanted to know what dosage of the vaccine is approved by DCGI considering that AstraZeneca has claimed that half a dose followed by full dose of the vaccine was found to be most effective while Indian participants were given two full doses.

During an all-party meeting convened, Prime Minister Narendra Modi had assured the country that the Covid-19 vaccination drive would commence in a few weeks.

Vaccination action plan

Making a presentation about Covid-19 vaccine roll-out in the country, the Health Ministry on Tuesday gave out a detailed action plan, if and when the DCGI gives accelerated approval for one or more vaccine. It also said that the plan in the near term is to vaccinate 30 crore Indians including one crore healthcare workers and two crore frontline corona warriors such as police and armed forces personnel, and municipality workers. People above 50 as well as those suffering from co-morbidities would also be in this priority group.

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