Pfizer/BioNTech submits EUA application for new crown vaccine.

Today, Pfizer and BioNTech announced that the two companies have filed an emergency authorization (EUA) application with the FDA for their new crown vaccine, BNT162b2.
an important milestone in the fight against the new global crown epidemic and gives hope that life will return to normal.
what we know about this vaccine right now? What happens next? Earlier this week, Pfizer and BioNTech released the latest results of the vaccine in Phase 3 clinical trials.
, 170 newly crowned confirmed cases have been analyzed so far in the clinical trial, which was attended by tens of thousands of people, according to a press release.
162 of them came from the placebo control group, accounting for the vast majority.
received the vaccine, and only eight people were eventually infected with the new coronavirus.
these results, the two companies announced that the vaccine had reached its primary therapeutic endpoint, with a vaccine effectiveness rate of 95%.
data oversight committee did not indicate any serious vaccine-related safety issues.
discussed by the Advisory Board? Public data on the vaccine is currently limited and is available in press releases from Pfizer and BioNTech.
more data on vaccines at the Vaccine Advisory Board meeting to be held in early December.
, according to the Associated Press, the FDA will release the results of the analysis internally before the meeting as a basis for the day's discussions.
could be about the performance of new mRNA vaccine technologies and any safety risks.
whether the vaccine should be approved, experts will also discuss practical applications, such as which groups are suitable for the vaccine.
older groups, adults with other diseases, younger health groups, children under 12 years of age, or pregnant women, have different considerations.
does not mean that Dr. Marion Gruber, the head of the FDA's office of vaccines, has been formally approved, even if it is authorized for emergency use.
, the FDA still sees it as a "research" vaccine.
this also means that every vaccinated individual receives a list of potential benefits and risks before vaccination.
's because we haven't seen the full picture of the vaccine yet.
we know it has a 95% effective rate, but this data is based on the volunteers who showed symptoms and were tested.
vaccine reduce the number of asymptomatic infections? How long can the vaccine last? These are outstanding issues and why we need to continue clinical research.
who receive a placebo injection, based on ethical considerations, will need to receive a real vaccine at some point in the future, which in turn will increase the complexity of clinical data analysis.
is more complex than actual production of conventional small-molecule drugs.
considering the huge demand, vaccine manufacturers need to ensure that the quality of tens of millions, if not billions, of doses of vaccines is consistent.
also suggests that the FDA is reviewing the vaccine, taking into account not only the safety and efficacy data of the vaccine itself, but also whether the vaccine is produced correctly.
the Pfizer/BioNTech vaccine and Moderna vaccine are among the new mRNA vaccine types, and no similar product has yet been approved by the FDA.
there is not much existing experience to draw on in the assessment of production methods.
can use the vaccine first? Pfizer and BioNTech could produce up to 50 million doses of vaccine by the end of the year.
to produce up to 1.3 billion doses of vaccine by the end of next year.
same time, the global population has exceeded 7.8 billion.
Reports from EndPoints suggest that Pfizer can begin delivering vaccines hours after the EUA application is approved, if approved, it is clear that not everyone will be able to get vaccinated in the first time.
U.S., consultants at the Centers for Disease Control and Prevention give advice on which populations will get the vaccine first.
, the global consensus is for medical personnel to take the lead in vaccinations and protect these health guards who are fighting on the front lines of the fight against the disease.
but after that? The situation is complicated by the fact that different countries and regions have different factors to consider.
, for example, young adults are a major group of viral infections and transmission, and some experts believe that vaccination for young children is of low priority (less exposure to these young adults).
india, however, many generations often live under the same roof, so both young adults and young children need vaccine protection.
, for example, in New York, the model estimates that 20 percent of the population has been infected with the virus, and the current rate of transmission is very low, so only an additional 40 percent of the population needs to be vaccinated to provide good population protection.
but in other regions, the figure will certainly be different.
faced with these complex issues, U.S. Secretary of Health and Human Services Dr. Alex Azar expects us to have a specific decision plan when the FDA decides.
Glory belongs to the thousands of hard-working Pfizer and BioNTech employees and billions of people at 43,661 brave volunteers at 150 active clinical trial centers 248 long days and nights, a historic moment that Pfizer Chairman and CEO Dr. Albert Bourla said on social media today.
, at the beginning of this year, the new coronavirus is still a strange virus full of too many unknowns.
by December, several vaccines had achieved excellent results around the world, and more were being developed.
, which traditionally takes years to develop, has delivered a remarkable answer this year at a record rate.
, we also pay high tribute to all the scientists and volunteers involved in vaccine research and development.
resources: PFIZER AND BIONTECH TO SUBMIT EMERGENCY USE REQUEST REQUEST TODAY TO THE U.S. FDA FOR COVID-19 VACCINE, Retrieved November 20, 2020, from Pfizer seeking to find the use of emergency use of its COVID-19 vaccine in US, Retrieved November 20, 2020, from Pfizer BioNTech is sending the first Covid-19 vaccine to the FDA, from Who will COVID-19 vaccines? Retrieved November 20, 2020, From The Touchy Math on Who Should Get a COVID Vaccine First, Retrieved November 20, 2020, from Pfizer, BioNTech to submit formal to FDA to authorize Covid-19 vaccine, Retrieved November 20, 2020, from the public eye of The Drug Mingkang