Britain has become the first Western country to approve a COVID-19 vaccine for general use, giving the green light to the Pfizer/BioNTech drug.
As authorities in the US and Europe probe other candidates, here is how countries have sped up their approval procedures to face up to the pandemic.
BRITAIN: ‘ROLLING REVIEWS’
Britain was able to approve the Pfizer vaccine after the independent Medicines and Healthcare products Regulatory Agency (MHRA) gave its all-clear. The MHRA used a “rolling review” process from June to assess the vaccine in record time.
Teams of scientists had worked “around the clock” on different aspects of the safety assessment, often tackling several topics in parallel, MHRA chief June Raine said.
Health Secretary Matt Hancock and others claimed that Britain’s departure from the EU had allowed it to approve the vaccine faster than its continental neighbours.
“Unlike the EMA (European Medicines Agency), they can ask questions as they go and obtain responses faster as a single agency,” said Penny Ward, professor in pharmaceutical medicine at King’s College London.
Raine insisted that “no corners whatsoever have been cut” in the vaccine approval process.
EU: ACCELERATED STEPS
The Amsterdam-based EMA, which regulates medicines across the 27 EU countries, has also turned to a “rolling review” process for safety and effectiveness data from COVID-19 vaccine developers.
All three of the most advanced candidates — Pfizer/BioNTech, Moderna and Oxford/Astrazeneca — have been subject to the scheme for several weeks already.
According to the EMA, the accelerated procedures are granted for medicines “that fulfil an unmet medical need on the basis of less complete data than normally required.”
US: ADVISORY COMMITTEE
Both Pfizer/BioNTech and Moderna have requested emergency use authorisation (EUA) for their COVID-19 vaccines from the US Food and Drug Administration (FDA).
But the American process is slower than the British one and involves a public consultation.
The FDA carries out its own analysis of the vaccine and calls on an independent advisory committee.
“The FDA process is a completely transparent process with independent experts commenting and asking questions and recommending or advising the agency,” Moncef Slaoui, scientific adviser to Washington’s Operation Warp Speed programme, said on Wednesday. — AFP
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