If – and this is a big if – all goes according to plan, it is plausible that all of the UK’s most vulnerable to Covid could be vaccinated against it by the end of April, officials say.
Richard Hatchett, executive director of the Coalition for Epidemic Preparedness Innovations (Cepi), says the benefit of protecting vulnerable people with a vaccine should not be underestimated, in human or economic terms.
“It would eliminate the biggest threat – that of a health service overflow,” he said. “This would make it possible to relax social distancing measures and gradually return to normal.”
Licensing may not be easy
Over the next few days, possibly weeks, all eyes will be on regulators. Pfizer submitted its test data to the United States Food and Drug Administration (FDA) on Friday. The same information will be sent to the European Medicines Agency (EMA) in Amsterdam and the Medicines and Health Products Regulatory Agency (MHRA) in London in the near future.
Publicly, most experts are optimistic about this process, perhaps aware of fueling hesitation about vaccines if they have doubts. Others, however, say it would be wise to anticipate surprises.
All of the limited data from the phase three trials published to date has been released by press release, and regulators – always aware of the confirmation bias – will want to go through it with a tooth comb. They will be reminded of unforeseen problems with earlier vaccines that had been rushed through licensing, most notably the swine flu vaccine in the United States of 1976.
Did the five percent who caught Covid after receiving the gunfire from Pfizer and Moderna all regroup near the end of the trial period, suggesting its protection is fading quickly? Was efficacy in older age groups evenly distributed among people aged 65 to 85 and is there enough data to find out? Were the side effects better tolerated by some than by others? Is two months of safety data enough for an mRNA vaccine that has never been used before? How safe are the manufacturing processes?
These are just a few of the many vital questions that regulators will ask themselves.
It is also unclear whether and how the FDA, EMA, and MHRA will cooperate in their decision-making. Two months ago, the MRHA allowed the Oxford vaccine trial to continue after a serious adverse event was reported, but the FDA pushed its heels down and suspended the US wing of the trial for longer. of a month.
It was not a good look and if stark differences emerge between regulators on licensing of new vaccines, public confidence could take a serious hit.
Nick Jackson, head of programs and innovative technology at Cepi, said drug regulators had “been working to coordinate” early on in the pandemic. However, he added that they could still come to different conclusions because “everyone has to make their own assessment of the risks and benefits”. The nuances between countries such as healthcare capacity, age profiles and the incidence of co-morbidities will all influence the final judgment of each regulator.
Supply issues could stop rapid deployment
If and when vaccines are approved, supply issues could also prove difficult. The government has made deals to secure 355 million doses of seven vaccines so far, but contracts are not publicly available and delivery times remain horribly vague.
For example, 10 million doses of the Pfizer vaccine – enough for five million people – would be “expected” before Christmas, but the delivery date for the remaining 30 million ordered is “next year.”
On the supply side, experts say the results of the Oxford AstraZeneca jab testing, which are not yet known to anyone, including the Oxford team, are heavily dependent on the experts.
So far only four million doses of this vaccine have been delivered, but as a local product the UK is leading the queue for the first 100 million vials. It is also easier to manufacture and distribute as similar products have been made in the past and it does not need to be supercooled.