FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine | FDA: “While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”

Related Information

• Pfizer-BioNTech COVID-19 Vaccine EUA Letter of Authorization
• Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers
• Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Patients
• COVID-19 Vaccines
• Emergency Use Authorization for Vaccines Explained
• Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
• Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry

What you need to know about the coronavirus pandemic on 11 December

COVID-19: What you need to know about the coronavirus pandemic on 11 December: Top stories: US vaccine advisory committee votes to approve Pfizer vaccine, Britain has vaccinated tens of thousands and Germany reports highest case number in a 24-hour period. 

COVID-19 situation update for the EU/EEA and the UK: As of 11 December 2020, 14 651 551 cases have been reported in the EU/EEA and the UK: Portugal (335 207). As of 11 December 2020, 365 293 deaths have been reported in the EU/EEA and the UK: Portugal (5 278)

WHO accused of conspiring with Italy to remove damning Covid report

WHO accused of conspiring with Italy to remove damning Covid report: The World Health Organization has been accused of conspiring with the Italian health ministry to remove a report revealing the country’s mismanagement at the beginning of the coronavirus pandemic – the publication of which was intended to prevent future deaths.

Italy was the first European country to become engulfed by the pandemic. The report, produced by the WHO scientist Francesco Zambon and 10 colleagues across Europe, was funded by Kuwait’s government with the objective of providing information to countries yet to be hit.

Evidence of SARS-CoV-2 RNA in an Oropharyngeal Swab Specimen, Milan, Italy, Early December 2019: We identified severe acute respiratory syndrome coronavirus 2 RNA in an oropharyngeal swab specimen collected from a child with suspected measles in early December 2019, ≈3 months before the first identified coronavirus disease case in Italy. This finding expands our knowledge on timing and mapping of novel coronavirus transmission pathways.

Trials to test combination of Oxford and Sputnik vaccines

Covid: Trials to test combination of Oxford and Sputnik vaccines: UK and Russian scientists are teaming up to trial a combination of the Oxford-AstraZeneca and Sputnik V vaccines to see if protection against Covid-19 can be improved.

When Can I Get the Covid Vaccine? All Your Questions, Answered

When Can I Get the Covid Vaccine? All Your Questions, Answered: Exactly 272 days after the World Health Organization declared Covid-19 a global pandemic, 90-year-old Margaret Keenan and 81-year-old William Shakespeare in the United Kingdom became the first two people in the world to receive a thoroughly tested Covid-19 vaccine. (Yes, China and Russia began vaccinating people much earlier, but it’s not clear how well-tested those vaccines are.) In fact, the race for a Covid-19 vaccine began less than two weeks after the world outside China learned of the disease, when the genetic sequence of the SARS-CoV-2 virus was published on January 11.

Top COVID-19 Vaccine Myths

Special Report: Top COVID-19 Vaccine Myths - NewsGuard: 

1. MYTH: The mRNA vaccines being developed for COVID-19 will alter human DNA.
2. MYTH: COVID-19 vaccines are not being tested against a placebo in clinical trials. 
3. MYTH: The COVID-19 vaccine will use microchip surveillance technology created by Bill Gates-funded research.
4. MYTH: Dr. Anthony Fauci will personally profit from a COVID-19 vaccine.
5. MYTH: A new law in Colorado will force parents into a government-run re-education program if they refuse to give their children a COVID-19 vaccine.
6. MYTH: The COVID-19 vaccine has been proven to cause infertility in 97 percent of its recipients.
7. MYTH: COVID-19 vaccines will contain aborted human fetal tissue. 
8. MYTH: The COVID-19 vaccine being developed by Oxford University and AstraZeneca will turn people into monkeys.
9. MYTH: Government food stamps will be denied to those who refuse COVID-19 vaccines.
10. MYTH: The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) will use artificial intelligence to monitor the safety of COVID-19 vaccines because the agency knows that vaccines are extremely dangerous.
11. MYTH: A document on the FDA website shows that two participants died as a result of “serious adverse events” from an experimental COVID-19 vaccine.
12. MYTH: The virus mutates so fast that a vaccine will never work.

How to Build Trust in Covid-19 Vaccines

How to Build Trust in Covid-19 Vaccines: Safe, effective, and available vaccines are the best long-term solution to the coronavirus pandemic. So it’s welcome news that two vaccines are poised for distribution and others will soon be on their way. Preliminary clinical trial data from these two vaccines, made by Pfizer and Moderna, indicate the vaccines are effective at stimulating a strong and long-lasting response against the virus responsible for COVID-19. A recent FDA briefing confirmed the efficacy and safety profile of Pfizer’s vaccine, reiterating the shot was 95 percent effective at preventing COVID-19 after two doses with no serious safety concerns.

This is all good news, but it’s still unlikely that a vaccine will be widely distributed until mid 2021.