Those most vulnerable to the coronavirus will only be recommended immediate access to upcoming vaccines if scientific data shows that it works better for them, the head of the European Medicines Agency (EMA) told the Irish Independent.
Our job is to examine the application and decide if there is a positive benefit-risk, “said EMA Executive Director Emer Cooke.” We will describe the indication of vaccines for the type of population for which it shows positive results.
“So whether it’s the elderly population, the pediatric population, or people with comorbidities, these are things that we will look at to see if there is enough data to back that up on the record.”
However, the final allocation and deployment of vaccines is decided at the member state level by a national immunization committee, opening up the possibility for national governments to differ with the drug regulator and the European Commission.
Europeans could have access to the first doses of a Covid-19 vaccine in a few weeks under a fast-track approval process for pandemic drugs at the EMA, according to Cooke, who took on the new job last week when Moderna announced it had a vaccine that was 95pc cash
“I think we are going to be very close,” he said. “Assuming everything is positive, and we have to look at the data to be sure, but in the best case, we could have a scientific opinion by the end of the year.”
EMA scientists have already begun a “continuous review” of data from clinical trials conducted by Moderna, Pfizer and the latest from Oxford / AstraZeneca. Cooke said the goal was to reach a positive recommendation in a similar timeframe to the FDA in the US, which is expected to have a verdict in mid-December on the Pfizer-proposed vaccine.
Pfizer announced two weeks ago that its vaccine was 94.5% effective. Oxford / AstraZeneca announced yesterday that it had a vaccine with an efficacy ranging from 62 to 90 percent, depending on the dose.
Ongoing reviews allow the authorization process to run in conjunction with clinical trials and prior to large-scale production or post-authorization studies, which typically must be completed before a new drug is marketed.
That means the EMA could quickly provide its scientific opinion for the European Commission’s marketing authorization, allowing manufacturers to distribute new vaccines as soon as they are produced.
“These have developed very quickly, which is very promising from a scientific perspective, but it means that there is a lot of focus on the results and we have to make sure we evaluate them as efficiently as possible without compromising our usual scientific standards.” “said Mrs. Cooke.
The EMA is also embarking on a public communication campaign to engage skeptics and encourage adoption once a vaccine is available.
The agency has hosted a virtual public meeting on December 11 and is inviting submissions and questions from interested members of the public and representative groups to address their concerns.
“We have recognized the exceptionality of this disease and the need for greater public participation,” said Ms Cooke.
“We want this to be a two-way dialogue, we want to hear what the concerns are, explain what the process is.
“We believe that it is very important that the community have confidence in the regulatory system.”