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.
1. India
Vaccines, drugs, and diagnostic tests need to be approved by the concerned regulatory authorities in every country before it can be rolled out.
In our case, this authority is the Central Drugs Standard Control Organisation (CDSCO). Such an approval is granted based on safety and efficacy assessment from clinical trials.
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.
The New Drug and Clinical Trials Rules, 2019 govern clinical trials of drugs and vaccines in India. While these don’t technically use the words ‘emergency use authorisation’, the term has gained relevance in the COVID-19 pandemic and has been used by regulators in other countries such as the US, reported The Indian Express.
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…”
2. The United States
According to the standards set by the US Food and Drug Administration (FDA), an Emergency Use Authorisation (EUA) can be granted when the known and potential benefits outweigh the known and potential risks of the drug being considered, and once sufficient efficacy and safety data from Phase 3 trials are available.
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.
“An EUA request for a COVID-19 vaccine should include all safety data accumulated from Phase 1 and 2 studies conducted with the vaccine, with focus on serious adverse events, adverse events of special interest, and cases of severe COVID-19 among study subjects. We recognize that the Phase 1 and 2 safety data likely will be of a longer duration than the available safety data from the Phase 3 trial at the time of submission of an EUA request. The Phase 1 and 2 data are intended to complement the available data from safety follow-up from ongoing Phase 3 studies.”FDA
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.
3. The United Kingdom
The decision by the UK regulatory authority to approve the Pfizer-BioNtech vaccine was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body.
The Medicines and Healthcare Products Regulatory Agency (MHRA) gave temporary authorisation to the Pfizer and BioNTech vaccine based on data submitted between 1 October and 2 December 2020.
The rapid approval has been credited to the ‘rolling review’ process – through which the regulators could study and analyse the data as and when it was submitted – instead of looking at it after the completion of the trials.
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:
“The data included results from the lab and clinical trials in humans, manufacturing and quality controls, product sampling, and testing of the final product. This process is designed to make sure that any approved vaccine meets the expected high standards of safety, quality and effectiveness.”
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.”
The US Food and Drug Administration commissioner Stephen Hahn also said in an interview, “We’re not going to take a summary from a company and take their conclusions and base our decision on that . . . We’re going to crunch the numbers ourselves.”
An MHRA spokesperson told the BMJ in defense, “Covid-19 vaccines, including this one, are being developed in a coordinated way that allows some stages of this process to happen in parallel to condense the time needed, but it does not mean steps and the expected standards of safety, quality, and effectiveness have been bypassed.”
(This was first published on FIT and has been republished with permission.)
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