Is Covid-19 Vaccine Approval Hasty? FDA Commissioner Defends the Delay


  • In a first, the UK has swiftly approved the Pfizer-BioNTech developed coronavirus vaccine
  • The drug regulators across various nations including the US and the EU’s basket of countries are working on expediting the approval process
  • US FDA Commissioner has separately defended the time being taken by the US drugs regulator in approving the Covid-19 vaccine

All eyes have been glued to the announcement for the distribution of the coronavirus vaccine since the pharmaceutical companies reported the efficacies of their respective Covid-19 shots in the Phase 3 trials. Earlier on 2 December, the United Kingdom became the first country to give the go-ahead for the coronavirus vaccine jointly developed by the New York-headquartered pharmaceutical giant Pfizer (NYSE: PFE) and the Germany-based biotechnology firm BioNTech (NASDAQ: BNTX).

With Britain’s vaccine approval, the United States, European Union and Japan have been left behind in the race to get the coronavirus vaccine. According to the drug regulators and medical authorities of Britain, a considerable section of frontline workers and vulnerable people are likely to get vaccinated by next week.

Also Read: MHRA approves Pfizer-BioNTech vaccine for the UK, will be available from next week

An emergency approval has been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom for the usage of the coronavirus vaccine invented by Pfizer and BioNTech.

Britain is expected to receive as much as 800,000 doses of the Pfizer-BioNTech coronavirus vaccine from the Belgium manufacturing facility of Pfizer following which the health authorities have been advised to start vaccinating the people who are at high risk of dying, and the people with severe symptoms and serious health conditions under treatment for Covid-19.

Response to Covid-19 vaccine approval

The expeditious approval of the coronavirus vaccine from one of the largest economies of the world has grossed a mixed bag of response from the local dwellers, as well as the various drug regulators of other countries.

The Commissioner of the United States Food and Drug Administration (US FDA) Steve Hahn has reacted, without criticising, to Britain’s move of a high-speed approval of the coronavirus vaccine. Commissioner Hahn has defended the stance of FDA in the time being taken to approve the Covid-19 vaccine saying that the experts have been working day and night, analysing the raw data reported by Pfizer and Moderna (NASDAQ: MRNA) in their particular Phase 3 clinical trials.

The European Union’s drugs regulator has separately criticised the speedy approval of the coronavirus vaccine. According to the European Medicines Agency, the extant and detailed examination procedures that have been incorporated by the regulator are relatively more appropriate as compared to the swift analysis conducted by British authorities. EU's drugs regulator’s approval process includes a higher number of inspections and has been based on evidential data.

FDA Commissioner defends delay

The administration has been analysing the data sets in a robust manner as compared to other drug regulators, Hahn claimed. The FDA is unlikely to provide any conclusive agreement in the approval process of the coronavirus vaccine developed by Pfizer or Moderna at least until 10 December. The FDA is already underway in reviewing and examining the raw data of Phase 3 clinical trials provided by Pfizer after the pharma company filed an urgent application for the approval of the Covid-19 vaccine on 20 November.

The US FDA is likely to make the approval decision after convening a couple of public hearings on 10 and 17 December before which the administration will issue the documents including the findings and assessment with regard to the emergency approval of the coronavirus vaccine sought by different pharmaceutical and biotechnology companies.

The FDA’s review of the raw data issued by Pfizer and BioNTech can take up to four months or even more as the officials are examining the critical points, rigorously checking the safety and efficacy standards, quality of manufacturing, the potential side-effects, the response from various ethnic groups and specific patients. For the Phase 3 clinical trials, Pfizer and BioNTech have tested the efficacy of the coronavirus vaccine on about 44,000 volunteers, whereas Moderna’s trials included 30,000 people.