If-and if it’s big-if everything goes according to plan, all the people most vulnerable to Covid in the UK Inoculation by the end of April, Officials say.
Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (Cepi), states that the benefits of protecting the vulnerable with vaccines should not be underestimated from a human or economic perspective.
“It will remove the greatest threat of overwhelming healthcare services,” he said. “It will ease the measurement of social distance and allow it to gradually return to normal.”
License may not be easy
In the next few days, perhaps weeks, all eyes will be on regulators. Pfizer handed over the study data to the US Food and Drug Administration (FDA) on Friday. The same information will soon be sent to the European Medicines Agency (EMA) in Amsterdam and the Medicines and Healthcare Products Regulatory Agency (MHRA) in London.
Publicly, most experts are bullish on this process and are probably aware that it encourages vaccine hesitation in case of doubt. But others say it’s wise to anticipate surprises.
All limited Phase 3 study data published so far have been distributed by press releases, and regulators-always aware of confirmation bias-will want to comb it through with a tooth comb. They will have unexpected problems with previous vaccines that were hurriedly approved, especially the 1976 US swine flu vaccine.
Did the 5% who caught Covid after having a shot of Pfizer and Moderna all cluster towards the end of the trial period, suggesting that their protection would decline rapidly? Did the effectiveness of the old group spread evenly across the 65-85 year old group? Do you have enough data to know? Were the side effects more tolerable than others? Are 2 months of safety data sufficient for a previously used mRNA vaccine? How safe is the manufacturing process?
These are just a few of the many important questions that regulators ask.
It is also unclear whether and how the FDA, EMA and MHRA will cooperate in decision making. Two months ago, MRHA cleared the Oxford vaccine trial to continue after serious adverse events were reported, but the FDA delved into its heels and suspended the US division of the trial for more than a month. Did.
It doesn’t look good, and public confidence can be severely damaged if there are significant differences between regulators regarding the approval of new vaccines.
Nick Jackson, Head of Program and Innovative Technology at Cepi, said drug regulators “worked to coordinate” from the start of the pandemic. However, he added, they could still come to different conclusions because “each has to make its own risk-benefit assessment.” Subtle differences between countries, such as medical capacity, age profile, and incidence of comorbidities, all influence the final decision of each regulator.
Supply problems can stop rapid deployment
If the vaccine is approved, supply issues also need attention. The government has so far signed contracts to secure 355 million doses of seven vaccines, but the contracts are not publicly available and delivery dates remain terribly ambiguous.
For example, 10 million doses of Pfizer vaccine (enough for 5 million people) are said to be “expected” before Christmas, while the remaining 30 million orders will be delivered “sometime next year.”
On the supply side, experts say there are many problems with the Oxford AstraZeneca Jab test results, which are not yet known to anyone, including the Oxford team.
The vaccine has only been given in 4 million doses so far, but as a homemade product, the UK is at the forefront of the first 100 million vials. In addition, similar products have been manufactured in the past and do not need to be supercooled, making them easy to manufacture and distribute.
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