Pfizer’s Covid-19 vaccine candidate, of which the UK Government has secured 10m doses for use ‘by the end of the year’, is ‘90%’ effective, the company has announced today.
The news follows Pulse’s world exclusive last week that a DES is due to be announced this week setting out how GPs will deliver Pfizer’s US vaccine candidate, and/or the vaccine being trialled at Oxford, before the end of the year.
These plans are now looking increasingly likely to translate to reality as Pfizer today announced that interim findings from its phase three study.
These show that the vaccine was ‘more than 90% effective’ in preventing Covid-19 in participants without evidence of prior infection.
More than 43,500 participants took part in the study, including 42% with diverse backgrounds, and ‘no serious safety concerns have been observed’, the pharmaceutical giant said.
The manufacturer added that it is expecting to be able to submit for emergency use authorisation to the US FDA in the third week of November, ‘after the required safety milestone is achieved’.
Vaccines pre-procured by the UK Government are already being manufactured, with the NHS set to be able to start administering them as soon as they are approved for use by the MHRA, the chair of the UK Vaccine Taskforce told MPs and Lords on Wednesday.
This includes 10m doses of the Pfizer vaccine, as well as four million doses of the UK leading vaccine candidate, which should be ready to go ‘by the end of the year’.
Further doses are expected ‘by Easter’ next year, the Government said.
Pfizer expects to produce ‘up to’ 50m doses globally in 2020 and ‘up to’ 1.3bn in 2021 ‘based on current projections’, it said.
However, concerns have already been raised about the ‘logistical challenges’ for GPs administering the vaccine, which must be kept at ‘ultra-low’ temperatures of below -70C.
Last week, Pulse reported that the vaccination may come in vials of 1,000 doses which may have to be administered within five days of being defrosted.
Pfizer and its partner BioNTech’s first interim efficacy analysis, conducted yesterday, found that protection is achieved seven days after the second dose and 28 days after the start of the two-dose schedule.
However, Pfizer said that the final efficacy percentage ‘may vary’ as the study continues to collect additional safety and efficacy data until its final analysis.
The study will also evaluate the potential for the vaccine to provide protection to those who have had prior exposure to coronavirus, as well as prevention against severe disease, it said.
Data from the full phase three trial will be submitted for scientific peer-review publication, the manufacturer added.
Meanwhile, participants will be monitored for long-term protection and safety for two years after their second dose of the vaccine, it said.
Dr Peter English, former GP and BMA Public Health Committee executive committee member, told Pulse there is a ‘pretty good chance’ of achieving population immunity, even if the Pfizer vaccine is only 90% effective.
Speaking in a personal capacity, he added: ‘The caveat, of course, is whether the vaccine prevent infection, or just illness.
‘If people, while protected from significant illness, can still become infected – and are able to transmit the virus to others – then we won’t get population immunity, just individual protection.’
Dr Andrew Lee, a GP and reader of global public health at the University of Sheffield, said he felt ‘guarded optimism’ about the news.
He told Pulse: ‘Certainly academics and the public health community will want to see the data.
‘But I don’t want to pooh-pooh it too much in the sense that if it is indeed 90% effective, that is of the same order as MMR – ie very effective for a vaccine. It’s easily double the effectiveness of a seasonal flu vaccine, so even if the company’s figures are bloated it’s still good.’
However, he added that ‘we’re not at the stage where we can lift restrictions anytime soon’.
He said: ‘Even if general practice worked hard it would be a few months at least – as it’s two doses – just to immunise the high risk groups and health workers, never mind the wider public.’
The Government could ‘possibly’ roll out the vaccine ‘a lot quicker’ if it had enough supplies and ran a ‘mass vaccination programme’ with the military, but it’s a ‘huge logistical undertaking that should not be underestimated’, Dr Lee added.
‘Especially because the cold chain requirements appear to be quite arduous’, he said. ‘It’s not just a case of fridging a vaccine – this is a vaccine that needs to be kept at -80C so it’s not simple to transport and store.’
Pfizer Chairman and CEO Dr Albert Bourla said: ‘Today is a great day for science and humanity.
‘With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.’
It comes as Pulse revealed last week that GPs will be paid £12.85 per Covid vaccination jab administered – making the campaign ‘cost neutral’ – although details of the DES are yet to be released by NHS England.
Practices taking part in the programme should prepare for a 1 December start, although the actual start date depends on when the MHRA can approve a vaccine.
Additional reporting by Nicola Merrifield