Updated: December 2, 2020 3:12:52 pm
Pfizer said Britain’s emergency use authorization marks a historic moment in the fight against COVID-19.
Written by Benjamin Mueller
Britain gave emergency approval on Wednesday to Pfizer Coronavirus Vaccine, ahead of the United States to become the first Western country to allow mass vaccines against a disease that has killed more than 1.4 million people worldwide.
The authorization to use the vaccine developed by Pfizer, an American pharmaceutical giant, and BioNTech, a much smaller German company, kicked off a vaccination campaign with little precedent in modern medicine, encompassing not only ultra-cold dry ice and trays of glass vials, but also a crusade against vaccine misinformation.
The spectrum of Great Britain beating the United States until approval – on a vaccine jointly developed by a US company, moreover – may intensify pressure on US regulators, who are already being criticized by the White House for not moving faster to get doses to people. And it has sparked a global debate about how to weigh the desperate need for a vaccine against the imperative of assuring people that it is safe.
Russia and China have already approved vaccines without waiting for the results of large-scale efficacy trials, a decision that scientists in some cases have said poses serious risks.
While the go-ahead bodes well for Britain, which broke away from the regulatory orbit of the European Union to approve the injection early, it will have no effect on the distribution of the hundreds of millions of doses that other rich countries have purchased. in prepaid contracts.
It also offers little relief to poorer countries that cannot afford to buy supplies in advance and may find it difficult to pay for both vaccines and the exceptional demands to distribute them.
The Pfizer-BioNTech vaccine must be transported at temperatures similar to that of the South Pole, a requirement that already dictates who will get vaccinated: Nursing home residents were supposed to be Britain’s top priority according to plans by an advisory committee, but a limit on the number of times Officials believe the vaccine can be moved before it loses effectiveness, meaning that National Health Service staff members will receive the injections first.
The government has been coy about how quickly it could supply hospitals after approval, but doctors and nurses were preparing to start vaccinating their colleagues in a few days.
For Britain, which has suffered one of Europe’s highest per capita death rates from the virus, the decision by its drug regulator testifies to a vaccination strategy that has been the most aggressive in the West.
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After the government enforced an old law allowing Britain to exit the European Union regulatory framework in public health emergencies, its Medicines and Health Products Regulatory Agency accelerated a review of the vaccine developed by New-based Pfizer. York, and BioNTech, a small German company.
Britain pre-ordered 40 million doses of the vaccine, which was 95% effective in a late-stage clinical trial. The government has ordered a catalog of different vaccines that are in development, in total, more than five doses for each person in the country.
He has pinned his best hopes on a vaccine developed by AstraZeneca, a British-Swedish company, and the University of Oxford, which is being vetted for emergency approval in Britain. Much of the world could trust it because it is cheaper and easier to store than Pfizer’s, but its regulatory path in the United States is unclear after scientists and industry analysts questioned the promising initial results.
The Chemistry Behind the Vaccine Pfizer-BioNTech has never before produced an approved vaccine. It is based on sending genetic instructions through a molecule known as “messenger RNA” to elicit an immune response. BioNTech had made a prescient bet on technology and then joined forces with Pfizer, one of the largest pharmaceutical companies in the world; they ended up delivering astonishing results, in a timeline unprecedented before this year.
The US Food and Drug Administration Plans to Decide emergency authorization for the Pfizer-BioNTech vaccine shortly after an advisory panel meeting on December 10. US officials have said vaccines could begin within 24 hours of approval.
Another American company, Moderna, and the National Institutes of Health have also developed a vaccine using messenger RNA that has been shown to be remarkably effective (94.1%) in large trials. Moderna recently said it would apply to the FDA for emergency approval which, if granted, could result in the first injections being given as of Dec. 21.
Read also | The government has not spoken of vaccinating the entire country: Health Secy
Britain’s power to approve vaccines before the European Union, which has its own drug regulator, applies for now only in emergencies. But it will become permanent after Britain consummates its separation from the bloc on Dec. 31, making the speed of Pfizer’s approval an early sign in the government’s eyes of the flexibility that the country will once be given. to be separated from the rest. of Europe.
However, Brexit has also taken a toll, depriving Britain’s drug regulator of the money it used to get from contracts with the European Union.
The European Medicines Agency, which regulates vaccines throughout the European Union, is expected to approve the same vaccine in mid-December, Germany’s health minister recently said, opening the door for vaccines to start before the end of the year. . While US regulators scrutinize raw data from vaccine manufacturers to validate the results of their trials, their counterparts in Britain and elsewhere in Europe rely more on analyzes from the companies themselves.
The British government has also gone directly to its medical regulator, asking it to conduct an emergency review of certain coronavirus vaccines rather than waiting for vaccine manufacturers to do so.
Pfizer has said it expects to be able to produce up to 50 million doses this year, about half of them for the United States. Since each person needs two doses, one month apart, up to 25 million people worldwide could start getting vaccinated before 2021.
The United States bought 100 million doses of Pfizer in advance and the European Union 200 million doses.
The approval came at a dangerous time in the pandemic in Britain, where the virus has killed 66,000 people and hundreds more every day. A third of England’s hospital systems cared for more COVID-19 patients in recent weeks than in the spring. Several intensive care units in central England were struggling to maintain emergency care.
And while closing restaurants and pubs for a month has halted the spread of the virus, it is being replaced by a new system of localized restrictions, with a concession for Christmas trips that scientists fear will lead to another spike in infections.
In a clinical trial, the Pfizer-BioNTech vaccine was shown to be especially effective among older adults, who are more vulnerable to developing severe COVID-19 and who do not respond strongly to some types of vaccines. It did not cause serious side effects.
Since Moderna’s vaccine is unlikely to be available in Britain until at least the spring, the government has not formally requested that it undergo an emergency evaluation.
As vaccines become widely available, the scientific feat of developing them will give way to the social and political problem of persuading people to take them. In Britain, the source of some of the most virulent modern misinformation about vaccines, just over half of people have said in surveys that they would definitely accept a coronavirus inoculation.
Safety concerns have only been accentuated by the speed with which vaccines have moved towards approval, even though British regulators have repeatedly said they were not taking shortcuts.
Beyond those challenges, manufacturers will need to quickly generate hundreds of millions, eventually billions, of doses of the vaccine and move them to hospitals, clinics and pharmacies without compromising what’s inside.
The vaccine developed by Pfizer and BioNTech makes this effort especially complex. It has to be stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until shortly before it is injected, which requires transporting it in boxes filled with dry ice. Moderna’s vaccine should also be frozen, but only to minus 20 degrees Celsius.
Those requirements, along with high costs, could substantially limit the number of countries and people that have access to those vaccines.
For that reason, much of the world had been eagerly awaiting the results from AstraZeneca and Oxford, which will cost only a few dollars per dose and are easy to store for long periods. Britain has also staked a considerable part of its vaccination strategy on the AstraZeneca vaccine, buying 100 million doses.
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