The US Food and Drug Administration (FDA) has authorized the first COVID-19 vaccine for emergency use in the United States. Millions of doses of the Pfizer and BioNTech coronavirus vaccine, which has been found to be 95% effective, will be soon shipped around the country so that vaccination can begin within days.
President Donald Trump released a video on Twitter, calling the news as a “medical miracle.” He said the first immunizations would take place “in less than 24 hours.”
Around 20 million could be vaccinated in the next few weeks — an important step toward ending the pandemic that has killed nearly 300,000 people in the United States.
“The FDAauthorization 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,” FDA Commissioner Dr Stephen Hahn said in a statement.
“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,” said Dr Hahn.
The authorization triggered a complicated coordination effort from Pfizer, private shipping firms, local health officials, hospitals, the military, and pharmacy chains to get the first week’s batch of about three million doses to healthcare workers and nursing home residents. And even as all this goes on, the vaccine must be kept at minus 70 degree C cold temperatures.
Besides, before vaccinations can begin, a US Centers for Disease Control and Prevention immunization advisory committee still must vote to recommend the vaccine, and the CDC must accept that recommendation.
An emergency use authorization means a medical product gets special authorization by the FDA to be used during an emergency — but it is short of a full approval. Pfizer would have to file a separate application for its vaccine to be fully licensed by the FDA.
A few days back, the UK’s Medicines and Healthcare products Regulatory Agency warned that people with a history of significant allergic reactions should not have the Pfizer/BioNTech Covid dose.
The warning came after two National Health Service workers in that country had allergic reactions on Tuesday (Dec 8). The two people had a reaction shortly after having the new jab, had treatment and are both fine now.