Japan health ministry to monitor health of early COVID-19 vaccine recipients
Nov 20 2020
BioNTech's logo is seen through a 3D-printed Pfizer logo in this illustration taken November 10, 2020.
Pfizer said on Wednesday morning that a final analysis of the Phase 3 trial of its vaccine found it to be 95 per cent effective and that it would seek emergency use authorization from the U.S. Food and Drug Administration "within days".
Adding to the encouraging data was that the efficacy was found to be consistent across all age-groups - a primary concern for a disease that hits the elderly the hardest - as well as genders and ethnicities.
Pfizer revealed on Thursday, November 19, that it can already submit the required two months safety data of BNT162's stage 3 trials to apply for a vaccine license from the Food and Drug Administration (FDA) in the U.S.as well as to worldwide regulators.
"If all goes well, I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively", Ugur Sahin said. Millions have lost their jobs amid partial lockdowns aimed at containing the spread of the deadly virus.The World Health Organization and regulators such as those in the USA and China had originally called for vaccines to be at least 50 per cent effective, so the latest vaccine study findings have far exceeded expectations.But concerns remain about vaccine safety and distribution, including access for developing countries.
Based on early conversations with the federal government, and using a per capita model, Ontario is expecting to receive 1.6 million doses of the Pfizer COVID-19 vaccine and 800,000 doses of the Moderna COVID-19 vaccine between January and March.
BioNTech's Sahin said USA emergency use authorization would be applied for on Friday.
About four percent experienced severe fatigue and two percent got severe headaches after their second dose.
Early results from ongoing trials show that we are able to design vaccines that elicit potent coronavirus responses in people over 60.
But he said that right now the discussions with provinces are still "at a preliminary stage".
Pfizer expects to produce up to 50 million doses of the vaccine in 2020 and up to 1.3 billion in 2021. The strategy is novel-no medicines made from mRNA have been approved for widespread human use so far. While meeting Pfizer's minus 70 degrees Celsius requirement for its vaccines will be "difficult", they are gearing up to set up cold chain storage for the jab job that needs to be done on an unprecedented scale of several crore shots to even begin with.
This is because they have different formulations of "lipid nanoparticles" used to deliver the mRNA molecules.
The final analysis comes just one week after initial results from the trial showed the vaccine was more than 90% effective. "And by the time the vaccine starts to be laid out, you may, as an individual, only have access to the vaccine in a month and a half or two months".