[ad_1]
The European Medicines Agency (EMA) announced on Thursday that its Committee for Medicinal Products for Human Use is evaluating the first batch of non-clinical data from laboratory studies on the Astra Zeneca vaccine, which is being developed in collaboration with the University of Oxford. The authority will continue to review the vaccine until it has enough information to make a decision.
“This does not mean that a decision can yet be made on the safety and efficacy of the vaccine as much of the evidence has not yet been presented to the committee,” the EMA said according to Reuters.
When the authority has completed its review, the authority will send its recommendation to the European Commission, which will make the final decision.
The main task of the EMA is to approve and review medicines in the EU. In acute health crises, the authority can use so-called “ongoing reviews” to accelerate the process of promising drugs and vaccines. This means that they review the data regularly instead of waiting until all the information is available in relation to a formal request.
Office of the European Medicines Agency in Amsterdam.
Photo: Peter Dejong / AP
Astra Zeneca welcomes the review and states that it is initially “an evaluation of existing preclinical data from studies conducted by the University of Oxford”.
“It will continue to review data from preclinical studies and ongoing clinical trials as they become available, in addition to this also data on vaccine quality control,” says the company’s press manager, Christina Malmberg Hägerstrand, in an email.
According to the Swedish vaccine coordinator Richard Bergström, involved in negotiations to buy vaccines for the EU, Astra Zeneca has already submitted data from phase 1 and 2 studies, animal studies, laboratory and manufacturing studies, but data from the phase 3 study, which still not complete remains. You think the purpose is to speed up the process.
– In this situation, it is not necessary that it takes longer than necessary, but it is not about lowering the requirements, it tells DN.
Pfizer / Biontech has started submitting data as well, but right now Astra Zeneca is a bit ahead of the other manufacturers on paperwork, he says.
– But they can be passed, it can be another company that has time to be approved before.
Astra Zeneca is collaborating with the University of Oxford on the development of the vaccine.
Photo: Adam Ihse / TT
In early September The Astra Zeneca study was temporarily suspended after a participant in the UK contracted transverse myelitis, a nerve disease that can occur after vaccination. The study has now been resumed in all affected countries except the United States after it was deemed safe to continue.
Now, three sources with knowledge of the matter claim that the US Drug Enforcement Administration (FDA) has expanded its investigation into the alleged side effect, writes Reuters.
According to sources, the FDA will now review data from previous studies of similar vaccines, developed by the same researcher at the University of Oxford. The FDA has requested information that would arrive this week and then the authority should have time to analyze it, say two of the sources who at the same time believe that this does not mean that the FDA believes that the other vaccines are unsafe.
– It just shows that the FDA is accurate.
Astra Zeneca states in the email to DN that the safety of clinical trial participants is of the utmost importance to the company.
“We are continuing to work with the FDA to facilitate the review of the information necessary to make the decision to resume the US study.”
Reuters has contacted the FDA, which does not want to comment on the matter, while the University of Oxford has not returned for comment.
Read more:
Astra Zeneca pauses vaccine trial after illness
Sweden Coordinator: Here are the most promising vaccines against covid-19
