LONDON – Britain on Wednesday gave emergency approval for Pfizer’s coronavirus vaccine, which jumped in front of the United States and became the first Western country to allow mass vaccinations against a disease that has killed more than 1.4 million people worldwide.
Authorizing the use of a vaccine developed by Pfizer, the U.S. pharmaceutical giant, and BioNTech, a much smaller German company, launched a vaccination campaign that had little precedent in modern medicine, not just ultra-cold dry ice and glass trays, but a crusade against misinformation against vaccines .
Britain’s ghost approving the U.S. – on a vaccine co-developed by a U.S. company – could increase pressure on U.S. regulators who are already on fire in the White House because they don’t move faster to get doses. And it has sparked a global debate on how to weigh the desperate need for the vaccine on the condition that people’s safety be ensured.
Russia and China have already approved the vaccines without waiting for the results of large-scale efficacy tests. This decision, according to scientists, carries serious risks in some cases.
While the sequel promises good Britain, which has broken off the European Union’s regulatory trajectory to approve the shot soon, it will not affect the distribution of the hundreds of millions of servings that other rich countries have procured in prepaid contracts.
It also provides little relief to poorer countries that cannot afford to buy supplies in advance and struggle to pay for vaccines and the exceptional needs of distributing them.
The Pfizer-BioNTech vaccine should be delivered at temperatures similar to the Antarctic, a requirement that already determines who will be vaccinated: The Advisory Committee planned that living in a nursing home should be a priority in the UK, but limiting the number of times it is believed that the vaccine can be moved before it loses its effectiveness, which means that National Health Service staff get the shots first.
The government has spoken about how quickly it can admit hospitals after approval, but doctors and nurses are prepared to start vaccinating their colleagues within days.
After the government ratified an old law allowing Britain to step out of the European Union’s regulatory umbrella in public health emergencies, the Medicines and Healthcare Products Regulatory Agency monitored a review of the vaccine developed by New York-based Pfizer and BioNTech , a small German company.
Britain ordered 40 million doses of the vaccine, which was 95 percent effective in a late-stage clincal study. The government has ordered a catalog of the various vaccines under development – a total of more than five doses will be given to each person in the country.
He placed his greatest hopes on a vaccine developed by the British-Swedish company AstraZeneca and Oxford University, which is being tested in the UK for emergency approval. Much of the world can rely on it because it’s cheaper and easier to store than Pfizer, but its regulatory path in the U.S. is unclear after scientists and industry analysts questioned promising early results.
The chemistry underlying the Pfizer-BioNTech vaccine has never produced an approved vaccine. It relies on sending a genetic instruction to trigger an immune response through a molecule known as “messenger RNA”. BioNTech made a prophetic bet on the technology and then teamed up with one of the world’s largest pharmaceutical companies, Pfizer; impressive results have been achieved, on a roadmap that was unprecedented before this year.
The U.S. Food and Drug Administration will decide on the emergency authorization of the Pfizer-BioNTech vaccine shortly after the December 10 meeting of the advisory board. U.S. officials say vaccinations could begin within 24 hours of approval.
Another U.S. company, Moderna and the National Institutes of Health, also developed a vaccine using messenger RNA that proved to be an extraordinary – 94.1 percent – test in large experiments. Moderna recently said it is seeking emergency approval from the FDA, which could result in the first injections being given as early as December 21st.
Britain’s ability to approve vaccines before the European Union, which has its own drug regulator, is so far only on an emergency basis. But it will become final after Britain implements its secession from the bloc on December 31, so the speed of Pfizer’s approval in the eyes of the government is an early sign of the flexibility the country will provide as soon as it breaks away. The rest of Europe.
Still, Brexit has also collected costs, starving the British drug regulator from contracts with the European Union.
The European Medicines Agency, which regulates vaccinations in the European Union, is expected to approve the same vaccine in mid-December, the German health minister recently said, opening the door for vaccinations to begin before the end of the year. While U.S. regulators are spying on raw data from vaccine manufacturers to verify test results, their counterparts in Britain and elsewhere in Europe rely more heavily on companies ’own analyzes.
The British government has also approached the medical regulator directly, asking it to conduct an emergency review of certain coronavirus vaccines and not wait for vaccinees.
Pfizer estimates it is expected to be able to produce up to 50 million batches this year, about half of which will go to the United States. Because every person needs two doses, with a monthly difference, up to 25 million people worldwide can start vaccination before 2021.
The United States pre-purchased 100 million servings from Pfizer and the European Union 200 million servings.
The approval came at a dangerous moment in the UK epidemic, where the virus killed 66,000 people and hundreds of people a day. One-third of England’s hospital systems have cared for more Covid-19 patients in recent weeks than in the spring. In central England, several intensive care units struggled to maintain emergency care.
And while shutting down restaurants and pubs for a month has paved the way for the virus to spread, it will be replaced by a new, localized restriction, allowing Christmas-waiting trips, which scientists fear, could cause another boom in infections.
In a clinical trial, the Pfizer-BioNTech vaccine was shown to be particularly effective in older adults who are more vulnerable to the development of severe Covid-19 and who do not respond strongly to certain types of vaccines. It did not cause any serious side effects.
As the Moderna vaccine is unlikely to be available in the UK until at least spring, the government has not formally requested an emergency assessment.
As vaccines become widely available, the scientific prowess of their development will give way to the social and political problem that will persuade people to take them. In Britain, which is the source of the latest modern disinformation about vaccines, just over half of people said in surveys that they would definitely accept vaccination with the coronavirus.
Safety concerns were only highlighted by how quickly the vaccines were moving towards approval, despite British regulators repeatedly saying they would not carry out a shortcut.
Beyond these challenges, manufacturers must quickly obtain hundreds of millions — and eventually billions — of doses of vaccines and deliver them to hospitals, clinics, and pharmacies without compromising their components.
The vaccine, developed by Pfizer and BioNTech, makes this effort particularly complex. Store at about minus 70 degrees Celsius (minus 94 Fahrenheit) and should be shipped in dry ice cans shortly before injection. Vaccination with Moderna should also be frozen, but only at minus 20 degrees Celsius.
These requirements, combined with high costs, can significantly limit the number of countries and people who have access to vaccines.
Because of this, much of the world was looking forward to the results from AstraZeneca and Oxford, which cost just a few dollars per serving and are easy to store for long periods of time. Britain has also tied a significant part of its vaccination strategy to vaccination with AstraZeneca, with the purchase of 100 million doses.