Pfizer & BioNTech Announce Good News for Vaccine
Updates from December 12th
The United States Food and Drug Administration has granted an Emergency Use Authorization to Pfizer and BioNTech, allowing them to administer their mRNA vaccine against the COVID-19 coronavirus. The news comes soon after the UK approved the same vaccine and began administering it by starting with the elderly and care home personnel and staff. The Pfizer vaccine just gained the EUA yesterday on Friday, December 11th, 2020 and allows administration within the USA.
It must be made clear, however, that this does not mean that the FDA has approved the vaccine. It only means that they have granted the companies an emergency authorization based on the current public health emergency which poses a โpotential to affect national security or the health and security of United States citizens living abroad.โ
The FDA Commissioner Mr. Stephen M. Hahn, M.D. says of the authorization: โThe FDAโs authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.โ He continues by saying, โTodayโs action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agencyโs career scientists to ensure this vaccine met FDAโs rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.โ
Updates from December 2nd
United Kingdom Health Secretary Matt Hancock has just announced that the Medicines and Healthcare Products Regulatory Agency of the European countryโs Department of Health and Social Care has approved the Pfizer and BioNTech mRNA COVID-19 vaccination. Moreover, the UK is ready to start administering the genetic vaccine to its citizens starting as early as next week.
According to HS Hancock, 800,000 doses will be made available in the UK and that the countryโs National Health Service will directly contact recipients themselves. The vaccine will be prioritised for the elderly, those in care homes, and some of the NHS staff. He says about the bulk rollout of the vaccine: โIโm confident now, with the news today, that from spring, from Easter onwards, things are going to be better. And weโre going to have a summer next year that everybody can enjoy.โ
UK Prime Minister Boris Johnson stated, โItโs the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.โ
Updates from November 20th
Pfizer and BioNTech, one of the collaborative teams working on a COVID-19 vaccine, has announced successful completion of Phase 3 of their trial, reporting 95% effectiveness after 28 days of the first doseโs administration in the 170 confirmed cases. The 170 participants that were evaluated included people of all ages, genders, races, and ethnicities. Participants aged over 65 years showed a success rate of 94% as well.
The pharmaceutical companies will now be moving towards availing the Emergency Use Authorization (EUA) now that the safety data milestone for the FDA has been achieved. The team observed that no serious safety concerns were found except for a 2% frequency of fatigue at 3.8% and headache at 2.0%.
Reporting for November 10, 2020
Pharmaceutical companies from America, Pfizer, and Germany, BioNTech have announced yesterday on Monday, November 10th, 2020 that their coronavirus vaccination team has finally achieved success with over 90% effectiveness in the first interim efficacy analysis for their BNT162b2 mRNA based vaccine candidate amongst participants who did not have any prior evidence of the COVID-19 viral infection. Following this announcement, the United States of America and the United Kingdom have started planning the deployment of the vaccine.
The mRNA or the โmessenger RNAโ is a versatile substance used as a messenger with the RNA cell to send genetic instructions into cells. The idea behind this mRNA BNT162b2 vaccination is that it uses the mRNA to basically trick cells into the production of protein bits that look like the coronavirus. The immune system of the person with the injected vaccine observes and recognizes the protein bits and learns how to combat them faster when they attack.
The new Pfizer x BioNTech vaccine has been planned to be submitted for the Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) after it reaches a required safety milestone in the third week of November 2020. It has been observed by the pharma companies that it takes 28 days after the initiation of the vaccine for it to achieve protection for the personโs cells. The vaccine would consist of 2 doses and would likely have to be administered periodically according to Pfizer CEO Albert Bourla when a CNN correspondent spoke to him on the matter.
At the moment, 94 cases of the virus have been confirmed in the trial participants from amongst the 43,538 enrolled participants. The goal of the Phase 3 trial is to reach 164 cases of the infection. After that, the vaccine will be licensed, and eventually, 50 million doses will be rolled out for 2020 and 1.3 billion doses for 2021. While the collective amount does not cover every single person on the planet, it would be a positive start and is meant to motivate the other 9 to 10 pharmaceuticals to keep working on finalising their own vaccines so that every person can be vaccinated. It is expected that the vaccine will be available for administration by December after a necessary 2 months have passed after the participants get their second doses of the vaccine.
Meanwhile, Matt Hancock, the British Secretary of State for Health and Social Care has asked the National Health Service system of the United Kingdom to start preparing for deployment of the COVID-19 vaccine. The plan for the UK is that they will begin with vaccinating the residents and staff of care homes, the staff of the NHS and social care, and then the British elderly. According to Sky News, he has also revealed that the Armed Forces will be supporting the NHS in the effort to get โready from the start of Decemberโ to deploy the viral infection vaccine.
The Vice President of the USA, Mike Pence also tweeted saying, โHUGE NEWS: Thanks to the public-private partnership forged by President @realDonaldTrump, @pfizer announced its Coronavirus Vaccine trial is EFFECTIVE, preventing infection in 90% of its volunteers.โ However, this tweet is untrue and Pfizer had no plans of using the $1.95 billion funding for development and only considered it an advance down payment on 100 million doses for the US federal government which would be administered to Americans free of charge.
HUGE NEWS: Thanks to the public-private partnership forged by President @realDonaldTrump, @pfizer announced its Coronavirus Vaccine trial is EFFECTIVE, preventing infection in 90% of its volunteers.
โ Mike Pence (@Mike_Pence) November 9, 2020
In an interview with The New York Timesโ Carl Zimmer and Katie Thomas, Pfizerโs Kathrin Jansen, the Senior Vice President and Head of Vaccine Research and Development stated, โWe were never part of the Warp Speedโฆ we have never taken any money from the U.S. government, or from anyone.โ She added saying, โWe have always said that science is driving how we conduct ourselves โ no politics.โ
This is a reminder that the coronavirus infection is on the rise again and that anyone could be a carrier, if not a confirmed viral patient. Remember to sanitize, wash your hands, and wear a mask everywhere.
Credit: AP
