This occasion is momentous considering the novel coronavirus was only sequenced 11 months ago and Pfizer/BioNTech began their first trials in early May. For many, this vaccine could not have arrived any sooner, as the UK has already witnessed about 62,000 deaths from the virus since the start of the pandemic, and in the last week over 107,000 people tested positive for Covid-19, despite the country just coming out of a second lockdown on December 2.
However, some European politicians and US public health leaders have expressed concern that the MHRA's approval process was complete well before the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) have finished processing data from the vaccine trials. Last week, the EMA indicated that more evidence was required before approval could be sought and the popular National Institute of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci suggested that the MHRA approval process was "rushed" before later apologizing and acknowledging the MHRA's leadership and experience as a regulatory body.
Devoid of evidence, these reactions might be considered reckless given the mounting issue of Covid-19 misinformation and vaccine hesitancy across the globe. The results from a panel study of 70,000 respondents in the UK carried out by University College London and released in September suggested that 22% of adults were unlikely to be vaccinated against Covid-19.
In fact, evidence from the MHRA approval process suggests that an efficient but stringent approval process was used by leveraging multidisciplinary teams, advanced planning, real-time data evaluation, independent reviews and strong leadership.
First, in June and then later in August, two multidisciplinary independent expert working groups were formed to prepare for and support the review process. Then in September, laboratories were equipped to carry out independent batch testing to test the safety and effectiveness of batches that would be sent by the manufacturers two months later. Throughout the process, the MHRA enabled Pfizer/BioNTech to send data from laboratory studies to clinical trials through a rolling submission process, allowing the regulatory body to assess results on an almost real-time basis. This made it easier to review the final data submission sent in the last week of November. The independent advisory body the Commission on Human Medicines was then asked to review the data separately before providing recommendations on the safety and effectiveness of the vaccine.
Finally, an EU legal provision was used to allow the UK to issue a temporary authorization to supply specific batches of the vaccine based on the public health need. This timeline tells us that strong leadership and close communication with the manufacturers has enabled an efficient review process.
All of this was managed under the strong leadership of Dr June Raine, who is also an experienced medicine and vaccine safety expert. She headed up the MHRA's Vigilance and Risk Management group for many years before taking on the role of Chief Executive in 2019 and has held the role of chair of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC). If anyone is going to put vaccine safety first, it is Raine. This is important because as we roll out the largest vaccination campaign in history, we will inevitably see new safety signals that need expert monitoring.
Furthermore, those who have worked with her can attest to her confident and calm leadership, which surely has motivated her team to work "around the clock," including on weekends, to support the review process.
Of course, not all of these attributes are unique to the UK alone -- despite the enthused claims made by some politicians in the UK. While the EMA approval process is very similar to the UK's, it is expecting to grant a conditional marketing authorization, which will enable countries across the EU to use the vaccine; this simply takes longer to complete. The US FDA process is also not all that dissimilar: Different groups of scientists will analyse the "raw data" and the FDA has requested the trial protocols from the manufacturers to understand the design and how the data was analyzed. The FDA's evaluation of the vaccine will certainly be useful for regulatory bodies across the globe, but at the same time the FDA could certainly learn from some of the efficient steps taken by the MHRA.
Finally, although the US FDA has been criticized for being too "bureaucratic" and "slow" in the past, its time line for reviewing the Pfizer/BioNTech vaccine is not too far off that of the UK's; a decision on the authorization of the vaccine is expected to take place in the next few weeks, if not the next few days, after an advisory panel meeting on December 10. A briefing released ahead of this meeting confirms the efficacy and safety profile of the vaccine.
As Keenan settled down after her vaccination Tuesday morning, she enthused that it was the "best early birthday present" that she could have wished for -- a wish I'm sure that she extends to everyone in the US and around the globe.
"Opinion" - Google News
December 10, 2020 at 03:03AM
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How the UK beat the US to Covid-19 vaccine authorization - CNN
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