Pfizer and BioNTech say European Medicines Agency to review data from COVID-19 vaccine trial on rolling basis

The Muslim Times has the best collection of articles for the war against Covid 19, especially the vaccines.

Source: Market Watch

By Ciara Linnane

Pfizer Inc. PFE, +1.01% and BioNTech SE BNTX, +9.49% said the European Medicines Agency has decided to review data from their COVID-19 vaccine candidate on a rolling basis and has already started to evaluate data from pre-clinical trials. The decision “follows the encouraging preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2,” the companies said in a joint statement. That combination of antibody and T Cell response is viewed as an important protection against viral infection and disease. A formal Marketing Authorization Application may follow if the vaccine proves efficacious and safe and submitted data are adequate, the statement said. The vaccine candidate is currently in a Phase 3 trial at more than 120 clinical sites around the world and has enrolled about 37,000 participants. “By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether or not the investigational medicine or vaccine should be authorized,” the companies said. “After a positive opinion, if adopted by the CHMP, it is the European Commission’s role to grant a Marketing Authorization.” Pfizer shares were up 2% premarket, while BioNTech shares were up 10%.

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4 replies

  1. (CNN)The US Food and Drug Administration made clear Tuesday it will want to see two months of follow-up data after volunteers get their second dose of vaccine as part of clinical trials testing potential coronavirus vaccines.

    That would make it difficult, if not impossible, for any vaccine maker to apply for emergency use authorization by Election Day, as President Trump has suggested, or by the end of October, as the CEO of Pfizer has hinted.
    The process will also make it “pretty darn hard for mischief,” National Institutes of Health Director Dr. Francis Collins said.
    The agency posted new guidance for manufacturers that says they need to provide at least two months of follow-up safety data after vaccinating volunteers before even asking the FDA to consider giving emergency use authorization (EUA) for a vaccine.

    https://www.cnn.com/2020/10/06/health/fda-covid-vaccine-safety-data-bn/index.html

  2. Johnson & Johnson said it has paused further dosing in all clinical trials of its experimental Covid-19 vaccine because a study volunteer had an unexplained illness.

    The pause announced Monday affects all trials of J&J’s vaccine, including a large Phase 3 trial that began in September and aimed to enroll as many as 60,000 people in the U.S. and several other countries.

    An independent data-safety monitoring board is reviewing the study subject’s illness, the company said. The company didn’t immediately disclose more information about the illness, and said it needed to respect the subject’s privacy.

    This is the second time trials for a Covid-19 vaccine trial have been paused over a safety concern. Last month, AstraZeneca PLC paused clinical trials of an experimental Covid-19 vaccine after a participant in a U.K. study had an unexplained illness. The U.K. study resumed, but a large U.S. study is still on hold.

    J&J, of New Brunswick, N.J., said illnesses and other side effects are an expected part of any clinical study, and it has prespecified guidelines to monitor for the events.

    https://www.wsj.com/articles/johnson-johnson-pauses-covid-19-vaccine-trials-due-to-sick-subject-11602555101?mod=hp_lead_pos1

  3. The new coronavirus may remain infectious for weeks on banknotes, glass and other common surfaces, according to research by Australia’s top biosecurity laboratory that highlights risks from paper currency, touchscreen devices and grab handles and rails.

    Scientists at the Australian Centre for Disease Preparedness showed SARS-CoV-2 is “extremely robust,” surviving for 28 days on smooth surfaces such as glass found on mobile phone screens and plastic banknotes at room temperature, or 20 degrees Celsius (68 degrees Fahrenheit). That compares with 17 days survival for the flu virus.

    https://www.bloomberg.com/news/articles/2020-10-11/coronavirus-can-persist-for-four-weeks-on-banknotes-study-finds?sref=eGA8az79

  4. Pfizer and BioNTech Coronavirus Vaccine Accepted for Rolling Review in Canada

    No estimate was provided as to when Health Canada might complete its review; the two companies wrote that the regulator “will not make a decision on whether to authorize any vaccine being considered under rolling review until it has received the necessary evidence to support its safety, efficacy and quality.”

    BNT162b2 is currently in phase 3 clinical trials, having reached that stage relatively quickly. As such, it is considered by many observers and pundits to be the leading COVID-19 vaccine candidate for approval.

    According to Pfizer and BioNTech, around 37,000 participants have been enrolled in more than 120 testing sites around the world in the trials. Twenty-eight thousand of those patients have received the second dose of the two-dose vaccination.

    https://www.fool.com/investing/2020/10/12/pfizer-and-biontech-coronavirus-vaccine-accepted-f/

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