A vaccine against COVID-19 has come a step closer with the announcement of the first results of a large scale clinical trial, which shows the vaccine is 90% effective.
The news has been hailed as a breakthrough against the pandemic that has so far claimed almost 50,000 lives in the UK.
Pharma giant Pfizer and immunotherapy company BioNTech have announced results of the first interim efficacy analysis of the phase 3 trial, which shows the vaccine is more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.
The first interim efficacy analysis evaluated 94 confirmed cases of COVID-19 out of 43,538 trial participants. It is a placebo-controlled trial, and although not yet confirmed, it is thought that the majority of infections occurred in the placebo-group. No serious safety concerns have been seen so far, but safety and additional efficacy data continue to be collected.
The companies plan to apply for Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA), soon after the required safety milestone is reached, possibly as Practice Nurse went to press (in the third week of November).
Pfizer and BioNTech expect to produce 50 million vaccine doses in 2020, and up to 1.3 billion doses in 2021.
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of 8 November 2020.
The Pfizer vaccine is one of 11 vaccine candidates currently in clinical trials.
Health secretary Matt Hancock says he anticipates a mass roll out in the first part of next year, assuming the vaccine clears final safety hurdles, but has asked the NHS to be ready to start the vaccination programme from the start of December.
He told BBC Radio 4’s Today programme: ‘It is a promising step…we’ve seen the effectiveness data but we will not license a vaccine unless it is clinically safe and we haven’t seen the final safety data.’
The Government has bought 40 million doses of the vaccine, which has to be administered as two doses, 21 days apart.
ROLE OF GENERAL PRACTICE
Agreement has been reached with GPs to help deliver the vaccination programme. NHS England/NHS Improvement (NHSE&I) has issued urgent instructions to prepare for the programme. Practices will need to work collaboratively with primary care network groups, and although NHSE&I recognises that the programme will require an ‘all hands to the pump’ approach, initially one site will be designated per PCN to provide vaccinations.
Designated sites will need to be able to deliver the service 7 days a week, including bank holidays, between 8am and 8pm, if vaccine supplies allow. The aim will be to deliver 975 vaccinations a week from each site.
Further guidance from the JCVI is awaited, but provisional advice allocates priority to older adults in care homes, elderly patients, health and social care workers and high risk adults under the age of 65.
A national call-recall system will be set up to run alongside practices’ own processes to ensure maximum uptake.
Practices will be provided with the vaccines, needles, syringes, diluents and PPE.
An item of service (IOS) fee of £12.58 will be paid for each dose, paid as a single payment of £25.16 on completion of the second dose. If it is not possible to administer the second dose, a single IOS can be claimed.
A major hurdle to the mass roll out is the requirement for the vaccine to be stored at -70°C – unlike the majority of vaccines which are stored at around 4°C. Professor Gordon Dougan, infectious disease and vaccine specialist from the University of Cambridge, warned that this would pose a major logistical challenge, and bespoke refrigeration methods may be needed to ensure its wide deployment.
General practice nurses have reacted with consternation to national news reports about how the vaccine will be delivered. The Sun announced: ‘GPs could dole out the COVID vaccine on Christmas and Boxing Day under plans to protect millions of Brits quickly…Family doctors are being primed to offer the jab seven days a week between 8am and 8pm.’
One nurse commented on social media that she thought it was ‘hilarious’ to suggest that GPs would be giving the vaccines. ‘It will be nurses, HCAs and receptionists giving up their weekends’.
Some said they did not know how GPNs would cope, as they were already ‘booked solid’ and many hadn’t completed the seasonal flu campaign, and that it was ‘not deliverable in general practice with current workload’.
But others said general practice would be ideally placed to lead the way on the COVID-19 vaccination programme (CVP).
The BMA says it expects ‘the majority of patients will want to be vaccinated in general practice. Practices participating in the CVP will need to prioritise workload to ensure that patients can access COVID-19 vaccinations, flu vaccinations and “other urgent clinical needs”. ’
BMA GP committee chair Dr Richard Vautrey said: ‘GPs and their teams are uniquely placed to ensure that their communities are properly protected from this deadly virus. And with their proven track record in delivering widespread vaccination campaigns, such as this year’s flu programme, they are absolutely the right people to be leading this COVID vaccination drive.
‘But we are under no illusion that this will be an easy task. Not only are these very complex vaccines – for example they need special storage conditions – but a campaign of this scale will be a huge undertaking for practices already struggling to cope with the impact of the pandemic, as well as supporting the large number of patients with other healthcare concerns.’