Coronavirus: Britain’s power to approve vaccines before the European Union, which has its own drug regulator, applies for now only on an emergency basis. But it will become permanent after Britain consummates its split from the bloc on Dec. 31, making the speed of the Pfizer approval an early sign in the eyes of the government of the flexibility it will have once the country fully untethers itself from the rest of Europe.
Image
AstraZeneca’s vaccine, which is cheaper and easier to store than Pfizer’s, is also being vetted for emergency approval in Britain.
AstraZeneca’s vaccine, which is cheaper and easier to store than Pfizer’s, is also being vetted for emergency approval in Britain.Credit…Andrew Testa for The New York Times
Yet, Brexit has also exacted costs, starving Britain’s drug regulator of money it used to draw from contracts with the European Union.
The European Medicines Agency, which regulates vaccines across the European Union, is expected to make a decision about the Pfizer vaccine later in December. Like the F.D.A., the European Medicines Agency has scheduled a high-profile meeting with outside experts before approval.
Pfizer has said it expects to be able to produce up to 50 million doses this year, about half of them going to the United States. Since each person needs two doses, a month apart, up to 25 million people worldwide could begin vaccination before 2021.
The United States has bought 100 million doses in advance from Pfizer, and the European Union 200 million doses.
The approval arrived at a perilous moment in the pandemic in Britain, where the virus has killed nearly 70,000 people, and hundreds more each day. A third of England’s hospital systems were caring 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 a monthlong shutdown of restaurants and pubs has stanched the spread of the virus, it is being replaced by a new system of localized restrictions, with an allowance for Christmastime travel that scientists fear will seed another uptick in infections.
Image
A closed restaurant in Manchester on Monday. England is moving from a second national lockdown to a new and byzantine system of local restrictions.
A closed restaurant in Manchester on Monday. England is moving from a second national lockdown to a new and byzantine system of local restrictions.Credit…Mary Turner for The New York Times
In a clinical trial, the Pfizer-BioNTech vaccine proved 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 caused no serious side effects.
With Moderna’s vaccine unlikely to be available in Britain until at least the spring, the government has not formally requested that it undergo an emergency assessment.
As vaccines become widely available, the scientific feat of developing them will give way to the social and political problem of convincing people to take them. In Britain, the source of some of the most virulent modern disinformation 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 headed toward approval, despite Britain’s regulators saying repeatedly that they were not taking shortcuts.
Beyond those challenges, manufacturers will quickly need to make hundreds of millions — eventually billions — of doses of the vaccine and move them to hospitals, clinics and pharmacies without jeopardizing what is inside.
The Pfizer vaccine 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, requiring transportation in boxes stuffed with dry ice. Moderna’s vaccine needs to be frozen, too, but only at minus 20 Celsius.
Those requirements, along with high costs, could substantially limit the number of countries and people that have access to those vaccines.
The New York Times
Me: If some countries can afford to buy the vaccine and some can’t, one has to wonder if it will be free to those who live in countries which can afford to give it out for free, or not.
Ultimately, unless every country worldwide has the option to inoculate everyone with a vaccine, it is not going to go away, any time soon and future manifestations of Covid, could be much more severe and vaccines may only have a limited time, before they cease to work.
