A possible lack of consensus within the human drugs committee on the “acceptable” side effects of the Pfizer / BioNTech vaccine, or on the adequacy of clinical trials, is a scenario that could force the final decision of the European Medicines Agency (EMA) to the vote.
The most important question to be answered by the Committee for Human Medicines (CHMP) next Monday, at the extraordinary meeting scheduled to conclude its evaluation of the first covid-19 vaccine, will strike a balance between efficacy against SARS-CoV -2 and side effects.
“We have a large data package, which includes extensive information on vaccine safety and so far nothing surprising has emerged in clinical trials regarding safety, but it is in the hands of my experts deciding definitively on this issue, “EMA director Emer Cooke told Efe.
Unanimous verdict
There are no rigid criteria to be followed by these experts, who will have to carefully analyze what side effects are acceptable, which will depend on the scope of the vaccine: if a drug is very effective – more than 90% in this case – a little more of mild effects, than if it works in a lower percentage.
Scientists consider that, once the tests are completed, the chances of serious side effects are low, but the CHMP can vote, with a majority in favor enough to send a positive recommendation to the European Commission, which decides whether to authorize the vaccine, which expects a formality to be issued and the permit issued in a matter of days.
Cooke wants to “reach a consensus,” but stresses that “procedures allow voting” at the end of the evaluation. “We make sure we have a vote that masters that all experts are satisfied with the studies available,” he added.
But in the event of a “dissenting member”, the EMA would make public the opinion of the expert who does not agree with the majority, which is outlined and argued in the final document of the conclusions sent to Brussels.
Common side effects
Following the start of vaccination campaigns in the UK and US, Pfizer has started sharing more information with doctors and the general public about their drug with a future that it is already clear that their vaccine has only the usual side effects in these drugs.
The five-page document, aimed at countries that have started vaccinating, but which collects virtually the same information it will issue in the EU, reports 7 common symptoms in the 40,000 volunteers who received two injections in 21 days: fatigue, back pain head, muscle or joints, fever, chills and discomfort at the injection site.
Less common were other symptoms, such as nausea and swelling or redness around the “puncture”. The rarest cases were general malaise and inflammation of the lymph nodes, which occurred in about 1% of the individuals who received the vaccine, depending on the future.
“We demand that the issues be monitored for at least six weeks after vaccination, and we will ask for follow-up for one year after vaccination. But even with data from 40,000 subjects – the average for these vaccines – we may not it may have been put to detect something very rare and is only seen when it reaches a larger population, ”Cooke added.
Rear control
That is why the process of approving conditional authorization will take longer in the EU than in non-European countries: the EMA must define clear obligations for manufacturers.
“We need to ensure that we have processes in place to assess any possible new adverse effects observed in the population, that we can assess whether it is attributed to the vaccine and, if so, whether there are additional precautions to be taken,” he said. the head of the EMA.
Doctors will need to be alert for possible allergic reactions, which would be reflected in difficulty breathing, rash or bloating, and not vaccinate pregnant or breastfeeding women, a preventive measure common to most medications.
They should immediately report any suspicious reaction that may be linked to the injection and the pharmacist will be required by the EMA to closely monitor the vaccination campaign to quickly identify undetected side effects while maintaining the agency.
Vaccination of children under 16 is a pending issue and there is still not enough research, which Pfizer will also have to commit to studying.
In any case, the Pfizer vaccine – as will be the case with Moderna’s vaccine in January – will get a conditional authorization, which requires manufacturers to continue sharing the results of their long-term studies, in order to renew their permit annually until they receive final and final approval.