Pfizer/BioNTech to seek emergency vaccine approval in US Friday

The first Phase 3 coronavirus vaccine trial in the US is expected to begin next week. Here’s how the vaccine works

Pfizer, Moderna COVID vaccines could be ready for US use in weeks

Pfizer and partner BioNTech will request emergency approval for their coronavirus vaccine candidate on Friday.

It's a rare glimmer of hope in a brutal and battering pandemic year: in November, both Moderna and Pfizer reported that their much-anticipated COVID-19 vaccines are 95% effective in protecting people against getting sick with the disease. The panel will likely be asked to recommend whether the vaccine should be authorized for use and in which populations. Among the confirmed cases, eight received the experimental vaccine and 162 received a placebo - a shot with an inactive substance.

The FDA could authorize the vaccine broadly for the USA population or limit it to specific groups, such as the elderly or minorities.

The FDA staff will be combing through Pfizer's raw data, which the public doesn't have access to, rather than relying on the company's own results to determine the safety and efficacy of the vaccine.

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Health authorities say vaccines, and the protection they provide if enough people receive injections, will be key to allowing people to return to schools, workplaces and other establishments.

Earlier this month, Canada's Chief Public Health Officer said that when a coronavirus vaccine becomes available there will be a limited supply at first. On the safety side, the companies cites results from 38,000 study participants who've been tracked for two months after their second dose. But they are ready to share the information with the FDA and other regulatory agencies around the world.

The price of the BioNTech/Pfizer vaccine is expected to be around $20 (17 euros) per dose, with a booster shot to be taken 28 days after the first. The RNA in these vaccines directs the body to make spike proteins, the protein which makes up those tiny spikes on the outside of the coronavirus cell. The inspections serve as a check that manufacturers of drugs or vaccines can make quality products.

Earlier, BionTech co-founder Ugur Sahin told AFP earlier in an interview with Zoom: "The documents will be finalized today (Thursday) and tomorrow and submitted to the FDA". He said, "These achievements highlight the potential of mRNA as a new drug class".

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The UK has pre-ordered 40 million doses and should get 10 million by the end of the year. Recipients will need two doses, three weeks apart. Pfizer is gearing up to ship 50 million doses this year. The more people who can experience milder symptoms and recover at home, the less burden on the health care system and the less exposure that health care workers will have to the virus, which all contributes to better control of the pandemic.

She added that she is confident that by this time next year, they will have a vaccine available for anybody in British Columbia. It started Monday, when Moderna said its mRNA COVID-19 vaccine was 94.5% effective in a phase 3 trial. These containers can also be used for storage by refilling with dry ice. However, the United States government expects to approve the vaccine in the first half of December.

Moderna's vaccine can be stored for up to six months at -20C though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F). "Widespread success of coronavirus vaccines would be a huge boon to the world's health, because Pfizer and BioNTech alone can not meet the full demand". Ashley Thompson was the editor.

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