Pfizer, BioNTech to seek emergency COVID-19 vaccine nod on Friday

Pfizer, BioNTech to seek emergency COVID-19 vaccine nod on Friday”

Fauci said the coronavirus vaccines quickly created by Moderna and Pfizer are the result of "extraordinary" advances in medicine and the developers did not compromise safety or scientific integrity.

An Emergency Use Authorization (EUA) is expected to be submitted to the U.S. Food and Drug Administration (FDA) within days.

The trial involved 41,000 people worldwide.

Batalvi rolled up for a second dose, not knowing if it would be the vaccine or a placebo, last week.

Johnson & Johnson said it expects to have data needed to seek US authorization for its experimental vaccine by February.

Pfizer and BioNTech are now in Phase 3 trials on the vaccine as is fellow pharmaceutical giant, Moderna. Out of the 170 positive COVID-19 cases detected in the trial only eight were observed in the active vaccine group. The rest of the cases were in the placebo group given a dummy jab.

Authorization of vaccines for children will take longer.

Moderna, another pharmaceutical company, announced Monday that early clinical trial results show its vaccine is 94.5% effective. The worst adverse effects reported so far have been mild headaches (in 2.2 percent of the cohort) and fatigue (in 3.8 percent of the cohort).

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A study on COVID-19 patients in MI found that two months after hospitalization, 32.5% had a lingering cough or difficulty breathing and 11% reported new or worsening trouble caring for themselves.

In the trial, 42% of all participants are from diverse ethnic backgrounds and 41% are aged between 56 and 85 years old.

More vaccine good news is what we've all been waiting for.

They'll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom. Both the final stage trials of Pfizer and Moderna began on July 27, in the middle of a summer with few cases of covid, and received widespread media attention. Pfizer is promising 50 million doses by the end of the year. But remember: it's a two-shot vaccine. That's good news for a country such as the United Kingdom, but not such good news for developing countries which haven't got the money to place bids. "By contrast, two doses of the measles vaccine are 97 percent effective".

The UK has pre-ordered 40 million doses and should get 10 million by the end of the year. Canada signed a deal with the company in August to secure 20 million doses of the vaccine in 2021. " But given the moment we are in this pandemic and the process of developing the vaccine, I could not have asked for a better result".

Henry said that they are working on how they will roll out the vaccine and some of the logistical challenges that come with both vaccines. This part, chosen and capable of telling the cells how to react, was then coated in lipid before being injected into them. It can, however, be kept in normal refrigeration for up to five days, or up to 15 days in a thermal shipping box. "The Moderna vaccine also requires freezer temperatures, which is a little easier".

Initially, people will be vaccinated at hospitals and large medical centers because supplies will be limited, said Marion Whicker, deputy chief of supply, production and distribution at Operation Warp Speed, the federal initiative to speed development of Covid-19 drugs and vaccines.

"We can expect both agencies to conduct a very careful evaluation and we can rely on their conclusions", he said. The CDC plans to monitor recipient's health via text message for several weeks, including one or more texts per day during the first week.

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