[ad_1]
meIt’s news that many have been waiting for: the European Medicines Agency (EMA) has started an ongoing review process for the planned Covid-19 vaccine from Biontech and Pfizer. What sounds technical is something of a compliment to the developers.
Obviously, supervisors are so satisfied with the results so far of the first preclinical and clinical trials that they are ready to go through the time-consuming process in real time until approval. Normally, the approval process only officially begins when the sending company has all the necessary data and documents.
Mainz-based company Biontech and its US partner Pfizer can now move into the fast lane with their candidate BNT162b2: from now on, they can submit clinical trial data as soon as it is available. These are then immediately evaluated by the pharmaceutical committee responsible for the EMA. The procedure, which usually takes many months, could be shortened considerably in this way.
Biontech is the first German company and the second in Europe in which the EMA makes this great exception in the search for a vaccine against Covid-19. The Swedish-British company Astra Zeneca had previously received permission from the vaccine control body to proceed in this way. The main reason that supervisors get involved is the urgency with which an effective and safe vaccine is being sought around the world to combat the pandemic.
The stock market was positively excited by the news: By noon, Biontech’s share price had risen by more than twelve percent on occasions and peaked at more than 77 euros. Since the IPO in October 2019, the value of the paper has multiplied by more than six.
Source: WORLD infographic
Astra Zeneca and the Biontech / Pfizer team are far ahead in the global race for a vaccine against the novel coronavirus. Both are now in the final phase of clinical testing. At this stage of development, the planned vaccine is being tested in several thousand test subjects for safety, tolerability, and efficacy, while searching for an appropriate dose.
“As we work to develop a potential vaccine at an unprecedented rate to end this pandemic, it is our duty to ensure that we do so with the highest ethical standards and in accordance with sound scientific principles.” said Ugur Sahin, CEO and co-founder of Biontech. “We will continue to have a regular and open dialogue with the EMA throughout the ongoing review process.”
In fact, the initiation of such an ongoing review process does not yet mean that the vaccine in question will actually receive marketing approval. Approval for this is only given when drug supervisors are truly convinced of the effectiveness and safety of a vaccine.
193 vaccine projects, 42 in clinical trials
If this were the case in the future, theoretically there could be a release for market approval just a few days after the end of clinical testing and evaluation. The EU Commission will then have the final say on whether or not a vaccine will be approved in Europe.
In the US, the responsible regulatory authority, the FDA, granted the Pfizer and Biontech vaccine candidate so-called fast-track status to accelerate clinical development.
Around the world, major industrialized nations have long been competing to see who can get enough vaccines at an early stage. A difficult undertaking, because until now no one knows which of the many planned corona vaccines (the World Health Organization, WHO now has a total of 193 projects, 42 of which are already in clinical trials) will hit the market in the end.
Supervisors play an important role in this race, as the vaccine is likely to be available earlier in those countries where approval is granted first. At least if these countries have requested vaccine doses in advance from interested manufacturers.
For example, the EU Commission has reached a possible agreement with Biontech and Pfizer for the delivery of 200 million doses of vaccines and 100 million additional optional units.
However, manufacturers and supervisors emphasize that despite the global desire for speed, safety has the highest priority in vaccine development. Supervisors at the FDA immediately denied US President Donald Trump’s announcement that a vaccine would be available in the United States in time for the US presidential election in November.
If clinical trials are successful and supervisors approve the vaccine, Pfizer and Biontech plan to produce up to 100 million doses of BNT162b2 vaccine by the end of the year. According to the two companies, it should be 1.3 billion cans by the end of 2021, at least if everything continues to go as expected.
