Pfizer/BioNTech COVID-19 Vaccine Wins EU Green Light
Executive Summary
The first COVID-19 vaccine will shortly be available to the EU member states. The European Medicines Agency says that uncertainties remain over the ability of the vaccine to prevent transmission of the coronavirus and whether the new variant strain will render this and other vaccines less effective.
Shipments of the Pfizer Inc./BioNTech SE COVID-19 vaccine are expected to begin within days in the EU after the European Commission gave the product a conditional marketing authorization (CMA) on 21 December, just hours after a positive recommendation from the European Medicines Agency.
The president of the commission, Ursula von der Leyen, described the move as a “decisive moment in our efforts to deliver safe and effective vaccines to Europeans,” The commission had previously been expected to issue a formal approval on 23 December. (Also see "EU ‘Ready To Approve’ COVID-19 Vaccine On 23 December" - Pink Sheet, 17 Dec, 2020.)
The EMA said its human medicines committee, the CHMP, had completed a “rigorous” evaluation of the product, which has been named Comirnaty (BNT162b2) in the EU, and that it had decided that “sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorization.”
“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said Emer Cooke, the EMA’s executive director. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU member states.”
Speaking at a virtual press briefing, Cooke said the EMA had been “guided by the strength of the scientific evidence and nothing else.” The CHMP’s “thorough” evaluation meant that EU citizens could be assured of the safety and efficacy of the vaccine and that it met necessary quality standards, she noted. “However, our work does not stop here. We will continue to collect and analyze data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”
‘No Political Pressure’ On EMA
The EMA had been criticized for the time it was taking to evaluate the vaccine, after the UK and then the US issued emergency use authorizations for the product. The agency had initially said that the CHMP would make its recommendation at a meeting on 29 January, but later brought this forward to 21 January. It denied that this was done under any sort of external pressure, saying it was due to changes in the process as well as to the data provided by the companies.
Cooke told the briefing that “we put out a timeline of 29 December at the latest, and all during the process we have been constantly evaluating our systems and processes to see how we could expedite the evaluation. We actually decided together that we would be able to do a few more things in parallel. In fact, the information was more convincing than we had originally anticipated, and this allowed us to move forward with the evaluation today as opposed to next week.”
CHMP chair Harald Enzmann agreed, saying that “one of the good things about the European system is this big network and that the decisions are in the end made in the committee, with representatives from each and every member state.”
This means that “the option to pressurize here from one or the other corner is extremely limited, up to non-existent,” he explained. “Even more so, because in this case, with this procedure, you can be sure that each member state was highly interested and could find some resources to contribute to the assessment, meaning the focus was exclusively on the science.” There were too many people involved “to allow any political whitewashing,” Enzmann said.” It was “a scientific assessment, full stop.”
New Variant Fears
A key question with all COVID-19 vaccines will be how effective they are in preventing transmission of the virus, and, even more topically, whether the new, more highly transmissible variant of the virus being seen predominantly in the UK could render them less effective.
Marco Cavaleri, the EMA’s head of biological health threats and vaccines strategy, said that data would be collected from the ongoing randomized controlled trial of the Pfizer/BioNTech vaccine to evaluate its ability to prevent infection in individuals.
However, as far as transmission was concerned, Cavaleri said “we need specific ad hoc studies, most likely large epidemiological studies, that can run once there is a large amount of the population that has received the vaccine. So, recognizing that this is an important question, it looks like it will take a bit longer before we have a clear cut view of the potential of the vaccine to reduce transmission.”
On the new variant of the virus, he said that “in principle what would scare us is if we see multiple mutations, particularly on spike protein and on the receptor binding domain, that will really alter the antigenic profile of the virus with respect to these vaccines and render them incapable of neutralizing the virus.”
At the moment it is too early to say, and “we need to gain more experience,” Cavaleri said. “We will need to see the virus changing quite substantially before we can be in a situation to see that trouble is coming up,” and it may be necessary to see whether the vaccine needs to be adapted to incorporate the emerging strain. “For the time being we are not worried,” he declared.
Post-Approval Requirements
Under the CMA, Pfizer/BioNTech will continue to provide data from the ongoing main clinical trial of Comirnaty. “This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromized people, children and pregnant women, and whether it prevents asymptomatic cases,” the agency noted.
The companies “will also carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine as the manufacturing continues to be scaled up.”
Noting that certain side-effects may only become apparent after millions of people had been vaccinated, the EMA said that in line with the EU safety monitoring plan for coronavirus vaccines, the use of Comirnaty will be closely monitored and “subject to several activities that apply specifically to COVID-19 vaccines.”
Monthly safety reports will be needed for all COVID-19 vaccines, in addition to the regular updates required by the legislation, and studies will need to be conducted to monitor their safety and effectiveness as they are used by the public, the agency noted. “Authorities will also conduct additional studies to monitor the vaccines. These measures will allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory action to protect public health if needed.”
During the assessment of Comirnaty, the CHMP was supported by the EMA’s drug safety committee, the PRAC, which evaluated the product’s risk management plan, and by the COVID-19 EMA pandemic task force.