Britain says it plans to start injecting people with the Pfizer-BioNTech vaccine as early as Monday after becoming the first country to approve a COVID-19 vaccine following large-scale clinical trials.
The British government approved the use of the coronavirus vaccine on Wednesday, after the Medicines and Healthcare Products Regulatory Agency (MHRA) announced it had completed its safety review.
The decision marks a significant milestone in the battle against the pandemic, although challenges remain for poorer health systems in rolling out the vaccine.
“The MHRA's recommendation has been reached following an extremely thorough and scientifically rigorous review of all the evidence of safety, of effectiveness and of quality of the Pfizer BioNTech vaccine,” said Dr. June Raine, head of the MHRA, in a virtual press conference Tuesday.
“The data showed that this vaccine is 95% effective. It is effective in all the groups that were given the vaccine within the trial, irrespective of age, sex, race or country that they lived in.”
Raine explained that the approval was completed so quickly because regulators had implemented a process known as a “rolling review.”
“A rolling review can be used to complete the assessment of a promising medicine or a vaccine in a situation where time is of the essence in the shortest time possible. But — and this is a very important point indeed — that doesn't mean that any corners have been cut. None at all,” Raine said.
British Prime Minister Boris Johnson struck a note of caution in a press conference Wednesday.
"There are immense logistical challenges. The virus has got to be stored at minus 70 degrees [Celsius]. Each person needs two injections three weeks apart. So, it will inevitably take some months before all the most vulnerable are protected — long, cold months. So, it's all the more vital that as we celebrate this scientific achievement, we're not carried away with overoptimism or fall into the naive belief that the struggle is over. It's not,” Johnson said.
Pfizer is expected to deliver 800,000 vaccine doses to Britain in the coming days. The government has so far ordered 40 million doses, enough to vaccinate 20 million people.
Care home residents will be first in line, alongside front-line health care workers. The elderly and clinically vulnerable will be next. Healthy adults will likely have to wait several months.
Dr. Simon Clarke, a microbiologist at Britain’s University of Reading, told VOA that scientists still do not know if the vaccine will generate so-called herd immunity in a population.
“We don’t yet know whether this vaccine only prevents disease, i.e., getting sick, or whether it will also prevent people from contracting the virus and passing it on to people,” he said.
Convincing a skeptical public
“There's so much that we don't know about, and there haven't been enough trials. There hasn't been enough time to even find out if these vaccines are safe,” said Samantha London, a 38-year-old musician who lives in Brixton, a district in South London.
Fellow Brixton resident Abi Babalola said she would take the vaccine if it is offered.
“Definitely myself and my family will be taking it, because we need to get back to normal. I've had enough,” she said.
Poorer health systems lack the storage capacity to keep the vaccine at minus 70 degrees Celsius. Dr. Nonhlanhla Rosemary Dlamini, the World Health Organization’s representative in Malawi, said it could be some time before any vaccine is rolled out.
“The kind of equipment that many countries have, including Malawi, is not that ultra-cold chain kind of equipment. So, as we are doing our assessment, we look at that. But, however, we still do not know what kind of vaccine is going to come into the country,” Dlamini said.
Several developed nations have ordered millions of doses of the Pfizer-BioNTech vaccine. U.S. regulators are due to meet December 10 to discuss emergency approval for the Pfizer shots, and again a week later to discuss another vaccine produced by Moderna.
Another vaccine developed jointly by AstraZeneca and the University of Oxford has also reported successful early results. It can be stored at regular refrigerator temperatures.
Clarke is optimistic that the fight against the coronavirus has reached a significant milestone.
“By spring, I think we will be well on our way to returning to normal. I don’t expect we’ll be quite there by then, but we’ll be on our way. And I think the rest of the world can expect to see other vaccines which might be more useful, perhaps don’t need the cold chain that this vaccine requires,” Clarke said.
The first human cases of the coronavirus were identified in Wuhan, China, in December 2019. In less than 12 months, several new vaccines have been developed at unprecedented speed.