Pfizer and BioNTech planning for FDA approval for COVID-19 vaccine
Pfizer and BioNTech apply for emergency use authorization of their potential coronavirus (COVID-19) vaccine with the FDA. The Food and Drug Administration will process the request over the next couple of weeks with a scheduled advisory committee meeting to review the vaccine.
The COVID-19 vaccine by Pfizer and BioNTech has proven to prevent 95 percent of cases in initial studies and there is already a distribution plan if the FDA approves the COVID-19 vaccine. If the FDA approves this vaccine production initially be limited and rolled out in phases.
#COVID19 UPDATE: We will submit a request today to the @US_FDA for Emergency Use Authorization (EUA) of our mRNA vaccine candidate with @BioNTech_Group.
— Pfizer Inc. (@pfizer) November 20, 2020
The vaccine will be available starting with healthcare workers and the elderly with underlying health conditions will be the next phase of people to receive the vaccine. The following groups to receive the vaccine will be essential workers, teachers, people in homeless shelters, prisons, and children.
The late-stage trial of the COVID-19 vaccine involved more than 43,000 participants with the results of 170 confirmed COVID-19 infections. The study concluded that 162 infection cases were observed in the placebo group and the remaining eight cases were in the study group that received the two-dose vaccine.
Though the results of the studies are promising the storage conditions for the vaccine could prove a problem in widespread distribution. The vaccine requires special refrigeration of minus 94 °F and the competition vaccine by Moderna can be stored easily at minus 4°F.
The U.S. agreed to buy 100 million doses of the Pfizer and BioNTech vaccine that is apart of Operation Warp Speed for $1.95 billion in July. If approved, the vaccine would be on track to produce 50 million doses this year and nearly 1.3 billion doses for 2021.
We are submitting our first request for an #EUA in the U.S. for vaccine candidate #BNT162b2 against #covid19. We look forward to continuously providing data to various regulatory authorities as part of our rolling review process – including the @EMA_News. https://t.co/Lk7MTlwE5R pic.twitter.com/OjZ2IxiU3a
— BioNTech SE (@BioNTech_Group) November 20, 2020
This vaccine is also submitting proposals for regulatory agencies around the world including the Medicines & Healthcare Products Regulatory Agency in the United Kingdom and the European Medicines Agency. The leading disease expert in America, Dr. Anthony Fauci, believes the vaccine should be available to all Americans by April or July.
-
Secretary of State Antony Blinken calls for de-escalation as fighting displaces millions and raises concerns for upcoming Congo elections....
-
Taking Precautions in Uganda and Kenya for Safe Travels The U.S. Embassy has recently issued important security alerts for...
-
White House Reveals Disturbing Executions and Threats in Conflict The White House has disclosed deeply concerning information regarding the...
-
Military Exercises Coincide with Treaty Developments Amid Global Concerns Russia recently executed a large-scale military exercise to rehearse its...
-
China’s Ambitious Plans to Double Its Nuclear Warhead Stockpile Highlighted in Pentagon’s Annual Report The annual report released by...
-
Strengthening Partnerships and Providing Support in Challenging Times In a collaborative effort between the U.S. Congress and the White...
-
U.S. Stresses Peace and Humanitarian Aid in Israeli-Palestinian Conflict In an exclusive interview aired on Sunday, President Joe Biden...
-
Meta’s Oversight Board to Review Handling of Manipulated Biden Video Facebook’s refusal to remove a leaked video of President...
-
Congressman accused of credit card misuse and identity theft, as legal challenges persist. U.S. prosecutors have brought a fresh...
-
First-ever Criminal Prosecution of a Sitting President’s Child Sparks National Interest and Legal Debate In a landmark legal case,...
-
President Biden’s Performance Under a Strict Spotlight In the current climate of intense media scrutiny and heightened political divisions,...
-
Meghan, Duchess of Sussex, Rumored as Possible Contender for U.S. Senate Seat Recent reports have sparked speculation about Meghan,...