- People familiar with the matter said that the first injection may begin on December 7.
- According to media reports, the United States may urgently approve the plan as early as December 8-10, and begin shipping to all parts of the country within 24 hours after the announcement.
- BioNTech and Pfizer submitted data to the U.S. Food and Drug Administration (FDA) from a large-scale Phase 3 trial involving more than 43,000 people.
The UK will become the first Western country to approve the new coronavirus pneumonia vaccine, and independent regulatory agencies will approve it within a few days. According to insiders in the British government, the vaccine developed by BioNTech and Pfizer will begin delivery within hours of approval.
People familiar with the matter said that the first injection may begin on December 7. The UK has ordered 40 million doses of this two-dose product. Preliminary data show that this product is more than 95% effective in preventing coronavirus.
Before the Brexit transition ends on December 31, vaccines are usually approved by the European Medicines Agency (EMA).
However, in the case of urgent public needs, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom has the right to temporarily approve products.
The same approach can be used for vaccines developed by AstraZeneca and Oxford University. On Friday, the British government wrote to regulators asking them to review the AstraZeneca – Oxford vaccine. Russia approved a coronavirus vaccine in August, but this is not based on large-scale trial data.
The British government announced on Saturday that Nadhim Zahawi, Junior Minister of Commerce, will be seconded to the Ministry of Health as Minister of Health to oversee the production of the Covid-19 vaccine.
Earlier this month, BioNTech and Pfizer submitted data to the U.S. Food and Drug Administration (FDA) from a large-scale Phase 3 trial involving more than 43,000 people.
According to media reports, the United States may urgently approve the plan as early as December 8-10, and begin shipping to all parts of the country within 24 hours after the announcement.
These companies also provide data to EMA and the authorities in the UK, Canada, Japan, and Australia. Both EMA and MHRA are conducting an accelerated review of some candidate vaccines.
However, these regulatory agencies face an arduous task, which is to strike a balance between major public health needs and trust in safe and effective vaccines, which are essential to contain the epidemic.
June Rain, the head of MHRA, said: “The safety of the public is always the first. Our work is to work in accordance with the highest standards, and safety is our slogan.”
Pfizer and BioNTech vaccines will be the first vaccines to be licensed using mRNA technology, but they must be stored in an environment of minus 70 degrees Celsius during transportation and can only be stored in the refrigerator for up to 5 days before use.
British Health Secretary Matt Hancock told members of Parliament this week: “If these vaccines are approved, the NHS stands ready to roll them out as soon as safely possible.”
The British Joint Committee on Vaccination and Immunization recommends that nursing home residents and staff will be vaccinated first, followed by elderly people over 80 years old and general health workers.
Nadhim Zahawi, a junior minister for the Department of Business, tweeted “A big responsibility & a big operational challenge but absolutely committed to making sure we can roll out vaccines quickly-saving lives and livelihoods and helping us #buildbackbetter.”