India unlikely to get approval for Pfizer vaccine anytime soon; UK may get approval next week

With 95 per cent effectiveness against the Covid-19 infection, Pfizer’s coronavirus vaccine is likely to get regulatory approval from the UK government as early as next week. But with its super-cold storage requirement, India is unlikely to use Pfizer’s coronavirus vaccine any time soon or deliver it as a treatment for the Covid-19 infection in every part of the country.

Citing government sources, it said British regulators were about to start a formal appraisal of the coronavirus vaccine, made by Pfizer Inc and BioNTech SE, and that the National Health Service had been told to be ready to administer it by Dec 1. However, what we know now is Pfizer’s coronavirus vaccine is likely to get clearance for use as early as next week.

A spokesman said the authorisation process by the medical regulator Medicines and Healthcare Products Regulatory Agency (MHRA) is independent of the government and will take as long as they need to review the final data of Pfizer’s coronavirus vaccine.

However, the Pfizer coronavirus vaccine is unlikely to be made available in every corner of India and likely to be highly expensive. Pfizer’s coronavirus vaccine is an mRNA vaccine that is going to be very expensive in India. The Indian government has indicated that they are open to a dialogue with Pfizer so that the coronavirus vaccine can be made available for use in India.

Pfizer coronavirus vaccine has a super-cold storage requirement which is not available in most hospitals even in big cities. The coronavirus vaccine by Pfizer, which is based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, needs to be kept at minus 70 degrees Celsius (-94 F) or below.

With tight resources, rural areas in India and many poorer countries are likely to have a hard time in Pfizer’s coronavirus vaccine distribution. Plus, many hospitals in big cities also do not have the facilities to store vaccines at minus 70 degrees Celsius (-94 F) or below.

Earlier, Prime Minister Narendra Modi held a meeting with chief ministers of all the states and Union Territories to review the coronavirus situation and asked them to start working on cold storage facilities for coronavirus vaccine.

MODERNA TO REQUEST COVID-19 VACCINE APPROVAL IN US, EUROPE

American pharma giant Moderna has said it will request authorisation for emergency use for its coronavirus vaccine from the regulators in the US and European Union. The company has said the new analysis of its trial confirms that the shots given to volunteers offer strong protection against novel coronavirus infection.

Full results from a late-stage study showed that the Moderna coronavirus vaccine was 94.1 per cent effective with no serious safety concerns. It also reported a 100 per cent success rate in preventing severe cases.

“We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna Chief Medical Officer Dr Tal Zaks said in a telephone interview to Reuters. “We expect to be playing a major part in turning around this pandemic.”

In a statement, Modern said it plans to request EUA today from both the US Food and Drug Administration (FDA) and also “apply for a conditional marketing authorization with the European Medicines Agency (EMA)”.

Moderna vaccine claims 100% efficiency against severe cases of Coronavirus, seeks clearance