After ten months of doom and gloom, the Pfizer vaccine results give a ray of hope in the fight against Covid-19, and GPs are the right professionals to lead the vaccine campaign.
An interim analysis of a phrase 3 study has demonstrated that a vaccine candidate is 90% effective in preventing Covid in trial volunteers who were without evidence of prior infection of the virus.
According to Pfizer and BioNTech SE, a final data analysis is planned once 164 confirmed Covid cases have accrued. So far, there have not been any serious safety concerns reported by the Data Monitoring Committee. It recommends that the study continue to collect safety and efficacy data as planned. The companies plan to apply to the Food and Drug Administration for emergency use authorisation soon after the required safety milestone is achieved.
The company cannot apply for FDA Emergency Use Authorisation based on these efficacy results alone. More data on safety is also needed, and they are continuing to accumulate that safety data as part of their ongoing clinical study. At least two months of safety data following the second and final dose of the vaccine candidate is required by FDA’s guidance for potential Emergency Use Authoristion and the same will be available by the third week of November.
Of course, administering the vaccine will be tricky. This particular one has to be shipped and stored at –70° C or –80° C, which has never done in primary care before. That means maintaining the product on dry ice.
This vaccine is first of its type. Traditional vaccines are made up of small or inactivated doses of the whole disease-causing organism, or the proteins that it produces, which are introduced into the body to provoke the immune system into mounting a response. The mRNA vaccines, in contrast, trick the body into producing some of the viral proteins itself.
And by getting the human body to produce the viral proteins itself, mRNA vaccines cut out some of the manufacturing process and should be easier and quicker to produce than traditional vaccines.
Most work on using mRNA to provoke an immune response has so far been focused on cancer, with tumour mRNA being used to help people’s immune systems recognise and respond to the proteins produced by their specific tumours.
We still don’t know whether the proteins that have been chosen for the vaccine are the right ones to prevent a Covid infection in the body; how targeted the immune response is to this particular form of coronavirus; how long any immunity would last; or whether it causes side-effects such as increased inflammatory responses like redness and swelling or, in the worst case, aggravates disease.
But general practice is expert in mass vaccinations campaigns, and has credibility with local populations. Unlike Serco’s test and trace shambles, primary care can deliver this vaccine successfully if supported by resources and funding. The GPC and NHSE/I have agreed a DES for general practice to lead the delivery of the CVP (Covid-19 vaccination programme), so the profession will play its part to get back the nation to normalcy in the not-too-distant future.
Dr Kailash Chand OBE is a retired GP in Tameside