The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a COVID-19 vaccine developed by pharmaceutical companies Pfizer and BioNTech for use in the United Kingdom. With vaccinations in the UK beginning as soon as next week, the milestone marks the first of many COVID-19 vaccines seeking approval over the coming months.
Early on in the pandemic, German company BioNTech, which had several years of experience working with new mRNA-based therapies, primarily for cancer treatment, was quick off the mark in beginning development of a COVID-19 vaccine. By March, pharma giant Pfizer joined forces with the smaller company to help accelerate the development of this experimental vaccine technology, and human clinical trials kicked off in April.
Now, less than a year after the novel coronavirus first appeared, UK regulatory authorities have approved this vaccine for human use. The MHRA credits its rapid approval to a novel process referred to as a "rolling review." This regulatory mechanism allows for data to be evaluated concurrently while trials are ongoing. This process started in October as Pfizer and BioNTech began progressively delivering data to MHRA scientists.
Charlie Weller, head of vaccines at research charity Wellcome, calls this moment a “significant milestone.” He notes that although this rapid pace of development is unprecedented for a vaccine it does not mean corners have been cut. Instead, it points to an incredible collaborative global effort.
“This is a historic day and an important moment at the end of an incredibly difficult year,” says Weller. “For a vaccine to be developed, receive emergency approval and be ready to roll out in less than a year for a new virus is completely unprecedented. The speed of development for this and other vaccine candidates is testament to an extraordinary, collaborative, global research effort.”
The UK may be the first to approve this particular COVID-19 vaccine but other regulatory bodies are not far behind. The US Food and Drug Administration is set to convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10 to review emergency approval for the Pfizer/BioNTech vaccine.
The European Medicines Agency (EMA), which is responsible for drug approvals in the European Union (EU), has also been conducting a rolling review of the Pfizer/BioNTech vaccine since October and it is suggested a decision will be made before the end of December regarding EU vaccine approval.
Russia, on the other hand, has announced it will begin large-scale public vaccinations next week using its own COVID-19 vaccine, dubbed Sputnik V. President Vladimir Putin says more than 2 million doses of its vaccine will be ready within days, and the country's health minister, Mikhail Murashko, said 100,000 high-risk people had already been vaccinated.
The UK will initially have access to 800,000 doses of the Pfizer/BioNTech vaccine, which requires two doses administered several weeks apart for effective immunization. Healthcare workers and aged care home residents will be prioritized for the first wave of vaccinations with Pfizer/BioNTech supplying several million more doses to the UK over the coming weeks.
Liam Smeeth, an epidemiologist from the London School of Hygiene and Tropical Medicine, says the impact of a successful vaccine will take several months to become apparent. With much of England still under strict restrictions following a “circuit breaker” lockdown in November, Smeeth suggests it’s likely more restrictions will be necessary in early 2021 to contain viral spread until enough people are immunized.
“A route towards a much better situation in the UK is becoming clear,” says Smeeth. “A further circuit breaker in January or possibly February is likely to be needed. But, it is realistic to hope that by March or April the vast majority of older people, care home residents, and those with severe conditions will have been immunized. We can then work towards wider immunization – with ideally much of the population covered in time for next winter.”
Source: UK Government