FDA Officially Approves First Coronavirus Vaccine for Emergency Use


Under that agreement, the shots will be free to the public.

"This is serious business, and the current director of these CDC (Centers for Disease Control and Prevention) said yesterday we can expect similar numbers of deaths or more every single day for the next 60 to 90 days", he added.

It is mandatory for Pfizer Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death. It will save millions of lives and soon end the pandemic once and for all'.

President Trump backed the move saying: "The first vaccine will be administered in less than 24 hours".

USA biotechnology firm Moderna Inc. has also filed with the FDA for vaccine use authorization and an advisory committee meeting is scheduled next Thursday.

US President Donald Trump called the vaccine news a "medical miracle" and one of the "greatest scientific achievements in history" in a video posted to his Twitter account. Critics have said his focus on China was aimed at deflecting attention from his missteps in combating the pandemic.

The United States has given the final go-ahead to the nation's first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed almost 300,000 Americans.

Bahrain approves registration for Sinopharm COVID-19 vaccine
D-Day was the beginning of the end of the war and that's where we are today, Perna said a news conference yesterday. But he added that it would take months of work and diligence, courage and strength to eventually achieve victory.

Others with vaccines in advanced development include Moderna, which could win emergency US authorization as soon as next week, AstraZeneca Plc with Oxford University, and Johnson & Johnson. The vaccine contains a small piece of the SARS-CoV-2 virus's mRNA that instructs cells in the body to make the virus's distinctive "spike" protein.

Moderna's vaccine employs the same technology but does not need to be stored at sub-Arctic temperatures.

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA.

Biden said that earlier this week, he had announced that his COVID response team will scale up the manufacturing, distribution, and injection of the vaccine.

The Japanese government has an agreement with Pfizer to receive a supply of 120 million vaccine doses, enough for 60 million people, or roughly half its population, in the first half of next year. The status of those talks are unclear.

Two other vaccine candidates stumbled on Friday: Sanofi of France and GSK of Britain said their vaccine would not be ready until the end of 2021.