Pfizer’s COVID-19 vaccine becomes first to get emergency authorisation

UK government gives nod on basis of interim results, vaccine to be made available by next week  

By DTE Staff
Published: Wednesday 02 December 2020

The United Kingdom (UK) became the first country to give an emergency use authorisation (EUA) to the Pfizer-BioNtech novel coronavirus disease (COVID-19) vaccine. The UK government statement said the vaccine would be available for use in the next seven days.

A statement issued by Department of Health and Social Care December 2, 2020, read it has accepted the recommendation of Medicines and Healthcare products Regulatory Agency (MHRA) — the country’s drug regulator — following months of rigorous trials and a thorough analysis of the data by experts there.

Pfizer is a messenger RNA (mRNA) vaccine, which, once released into the body, would instruct the immune system to produce antibodies against spike proteins. A vaccine of this type has never been used before.

The spike proteins released by the vaccine mimic the spike protein of the novel coronavirus SARS-CoV-2. These proteins have been sequenced in the lab, so when the virus attacks in real, the antibodies would produce an immune response against them.

The vaccine needs to be stored at minus 70 degree Celsius. Two shots would have to be administered for the complete dose. In its interim results, the pharmaceutical firm had claimed an efficacy of up to 95 per cent.

“The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable,” the statement read.

It is important to mention here that an EUA is not a full approval. The full and final results of phase-III are awaited, on the basis of which the full approval would be granted.

The country had entered into agreement with the pharmaceutical firms to get 40 million doses in 2020 and 2021.

“Now that the vaccine is authorised in the UK, the companies will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the UK in the coming days, with complete delivery fulfilment expected in 2021,” Pfizer said in a media statement.

The company has also applied for an EUA in the United States, European Union and Canada. The decisions from US and other regulators are awaited.

“Based on current projections, Pfizer-BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorization),” the company said.

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