The COVID-19 vaccine from Pfizer/BioNTech received the green light from the UK health authorities on Wednesday. This set a new record for the shortest time required to develop an entirely new vaccine and get it approved for broad commercial use.
Previous to this success, the mumps vaccine was the fastest ever brought to market, with authorities approving the vaccine in 1967 after more than four years of development.
Normally, the development of new vaccines can take a decade or more, but it is only ten months since the American pharmaceutical giant Pfizer and the German biotech company BioNTech began work on their coronavirus syringe.
Approval by the British government – following a review by the independent British Medicines and Healthcare Products Regulatory Agency (MHRA) – was granted only twelve months after the first cases of COVID-19 had been recorded in China.
“This is a historic day and an important moment at the end of an incredibly difficult year. That in less than a year a vaccine for a new virus will be developed, receive emergency approval and be ready for market launch is unprecedented,” said Charlie Weller, Head of Vaccines at the Wellcome Trust, in a statement.
“The speed of development of this and other vaccine candidates is testament to an extraordinary collaborative global research effort,” said Charlie Weller, Head of Vaccines at the Wellcome Trust. This emergency approval by the MHRA is a significant milestone and very encouraging. This decision, which is independent of government or other external influences, paves the way for the introduction of this vaccine to a broader population.
The vaccine, which is reported to be 95 percent effective against COVID-19, is also the first vaccine based on “mRNA” technology to be approved for use in humans, a development that has been welcomed by scientists. The mRNA vaccine introduces tiny fragments of the genetic code of the SARS CoV-2 virus that causes COVID-19 into the body, enabling the immune system to build a defense against the disease.
“This is the first mRNA vaccine ever approved and this technology puts us in a much better position to develop other vaccine candidates and vaccines, including vaccines against currently unknown viral pathogens,” said Zoltán Kis of the Future Vaccine Manufacturing Hub at Imperial College London in a statement.
The COVID-19 vaccine currently in development by the U.S. pharmaceutical company Moderna is also based on mRNA technology. The company is currently seeking approval from authorities around the world for the vaccine, which is also reported to be around 95 percent effective.
Two COVID-19 vaccines have already been approved for limited use in Russia, but the decision to start administering these vaccines to small sections of the country’s population has been widely criticized by experts, as Phase III clinical trials to evaluate the candidate have not yet been completed.
Phase III clinical trials are large studies involving tens of thousands of people to investigate the safety and efficacy of drugs or vaccines. They are usually required before a vaccine or drug is approved.
China has also approved a vaccine for use by the military, although this candidate has also undergone Phase III clinical trials.
Despite the fact that the vaccine was developed and approved for use by Pfizer in such a short time, experts say that the British authorities have not compromised on the review.
“The news that Pfizer/BioNtech’s vaccine has received MHRA approval is indeed welcome. It reflects the amazing progress in advancing a vaccine to the point of human application and certainly sets a new standard for what can be achieved when sufficient resources and scientific focus are applied to global health,” said Dr Stephen Griffin, Associate Professor at the School of Medicine, University of Leeds, in a statement.
The graph below, provided by Statista, shows how many doses of COVID-19 vaccine the UK has secured.
“Importantly, while the administrative side of the regulation has been speeded up, no compromises have been made in assessing the safety of this or other vaccines in the pipeline. It is vital that a clear message is sent to eliminate the unhelpful and unfounded rumour mill that has already begun to spread misinformation.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) concluded on Wednesday that the vaccine “has met its strict standards of safety, quality and efficacy”.
The agency has been reviewing data from Pfizer/BioNTech’s vaccine trials for months, although the full data set has not yet been published. The European Medicines Agency has also reviewed data on the vaccine, while the Food and Drug Administration will discuss whether or not to approve the vaccine in the United States on December 10.
Although experts have welcomed the latest news, many warn that there are still significant logistical challenges to be overcome in the coming months.
“This announcement is not the end of the story and much remains to be done,” said Arne Akbar, President of the British Society for Immunology, in a statement.
“The introduction of the vaccine will be a logistical challenge and will rely on our dedicated health professionals across the country. In addition, building public confidence in the vaccine will be crucial to ensure the high uptake necessary to stop the spread of SARS-CoV-2 in our communities,” said Arne Akbar, President of the British Society for Immunology.
In addition, scientists in the UK warn that public health measures such as social distancing and wearing masks will still be necessary for some time, even if the vaccine is introduced.