Are the rules same during a pandemic?

In emergency circumstances, such as the one posed by the COVID-19 pandemic, faster mechanisms have been put in place for approvals based on sufficient evidence for safety and efficacy, however, this will be an interim approval. The final one follows the completion of trials and the complete availability of data, while the emergency authorisation makes it possible for the vaccine to be used for the time being.

How are these interim approvals different?

For pandemic-like emergency situations, the rules have a provision for an ‘accelerated approval process’, which would allow the approving of drugs or vaccines that are still undergoing trials – if they provide sufficient benefit – which is decided based on the available data. This is particularly applicable if the drug shows ‘remarkable’ effectiveness even from phase-2 trials, based on which Bharat Biotech’s Covaxin was considered eligible for approval, despite being in its phase 3 trials. According to the 2019 Rules, “In such cases, additional post licensure studies may be required to be conducted after approval to generate the data on larger population…”

How are the rules for approval different from India?

Notably, the EUA cannot be given based only on Phase 1 and Phase 2 trial results – and this is where it differs from India, where such a provision exists.

What is the efficacy bar set by the US?

The minimum efficacy bar set by the FDA for a COVID-19 vaccine is 50 percent – and this must be attained after the vaccine has been studied in over 3,000 participants –who are all to be tracked and monitored for any adverse event for at least one month post the administration. In its guidelines from October 2020, the FDA stipulated that data from Phase 3 studies should include a median follow-up of at least two months after the patient has received their final dose.

But, what is the approval process like?

While the MHRA had not published details about the approval process, a spokesperson told the British journal that scientists and experts had ‘carefully and scientifically reviewed the safety, quality, and effectiveness data – how (the vaccine) protects people from Covid-19 and the level of protection it provides’. Phase 3 data from the vaccine had still not been published. The agency added:

What is the authorisation process in usual circumstances?

In usual circumstances, authorisation in the UK follows the approval by the European Medicines Agency. However, in such emergencies, EU countries can resort to their own regulator for temporary authorisation. In October, the government made changes to the Human Medicines Regulations 2012 to allow the MHRA to grant temporary authorisation of a Covid-19 vaccine without needing to wait for the EMA. Experts in the United States have been found to criticise the approval process in the UK. National Institute of Allergy and Infectious Diseases director Anthony Fauci had earlier said that the US had the ‘gold standard of a regulatory approach’ and that ‘the UK did not do it as carefully’. He later apologised and requested to not be misconstrued, saying, “Our process is one that takes more time than it takes in the UK. I did not mean to imply any sloppiness even though it came out that way.”

FAQ: How COVID Vaccine Approval Process Differs in US, UK & India?

Within a year of the COVID-19 pandemic striking the world, vaccines against the virus have started being administered in some countries. A few others, like India, are gearing up for the vaccination drive, even as the late-stage clinical trials are underway.

The Pfizer, Moderna and Oxford-AstraZeneca vaccines have been approved in multiple countries.

As vaccines begin to be rolled out after due evaluation by regulators, we take a look at the approval processes adopted by India, United States, and United Kingdom to understand what are their rules and regulations for emergency authorisations.

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FAQ: How COVID Vaccine Approval Process Differs in US, UK & India?

As vaccines begin to be rolled out, we take a look at the approval processes in different countries.

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