Pfizer/BioNTech to submit COVID vaccine for approval as latest data show it to be 95% effective

Pfizer and BioNTech plan to submit their COVID-19 vaccine for approval 'within days' after latest data from its phase 3 trial showed it to be 95% effective at preventing the coronavirus.

(Photo: Justin Tallis/Getty Images)
(Photo: Justin Tallis/Getty Images)

The final efficacy analysis from the trial also showed that the vaccine was 94% effective in adults over 65 seven days after the second dose was given, and that it worked equally well in people of all races and ethnicities. The data represent an improvement on the initial trial results, released on 9 November, which suggested an efficacy rate of 90%.

Pfizer and BioNTech said the vaccine has also now met the safety criteria for emergency authorisation in the US and they plan to submit it for approval from the US Food and Drug Administration (FDA) 'within days'. They added they would also submit the data for approval from other authorities around the world.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) will be responsible for approving the jab. A change in law earlier this year allows the MHRA to approve a tested, unlicensed vaccine against COVID-19, provided it meets all required safety, quality and effectiveness standards.

COVID-19 vaccine

The Pfizer/BioNTech vaccine looks set to be the first COVID-19 vaccine rolled out as part of a UK vaccination programme. The government already has advance orders in place for 40m doses. Following publication of the first data from its phase 3 trial on 9 November, England's deputy CMO Professor Jonathan Van Tam said he was hopeful the UK would 'begin to see some vaccine by Christmas'.

The companies have said that they expect to produce 50m doses of the vaccine in 2020 and up to 1.3bn by the end of next year.

Pfizer and BioNTech's phase 3 trial began in July and has enrolled 43,661 people around the world. Some 41,135 people have received a second dose of the vaccine or placebo. The current analysis is based on 170 cases of COVID-19, only eight of which were in the vaccinated group.

The companies said no serious safety concerns had been observed during the trial. The most common adverse events were that 3.8% of trial participants experienced fatigue and 2% headache following the second vaccine dose.

Today's news follows US biotech company Moderna publishing initial results from phase 3 trials of its vaccine on Monday (16 November), which was shown to be 94.5% effective in preventing COVID-19. The government has placed an initial order for 5m doses of that vaccine, however it is unlikely these will be available in the UK before spring 2021.

Vaccination campaign

Those vaccinated with the Pfizer/BioNtech jab require two doses, three weeks apart. However, using the vaccine poses a logistical challenge for the NHS. It needs to be kept at a temperature of -70 degrees Celsius and it only has an effective life of five days when moved to a fridge with a temperature between 2 and 8 degrees Celsius.

LMCs have reported that the vaccine will also need to be diluted before delivering it to patients.

GP practices have been told to be prepared to begin a COVID-19 vaccination campaign from early December. On 9 November NHS England sent out details of an indicative enhanced service saying that practices would be expected to work collaboratively across a PCN to deliver the COVID-19 vaccine - particularly in the early months of the programme.

However, GPs have warned of 'unrealistic expectations' over delivering the programme in general practice. There are concerns that vaccinations could to take as much as four times longer than flu jabs during the pandemic.

Meanwhile GPs have also raised concerns about the complexities of administering the vaccine, whether practices will receive funding to cover the costs involved and the fact they will be taking on the campaign against a backdrop of existing heavy workload.

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