NEW YORK: US regulators have given the final go-ahead to the country's first Covid-19 vaccine from Pfizer and its German partner BioNTech, marking the beginning of the end of a catastrophic outbreak which has killed nearly 300,000 Americans in just 11 months this year.
The US joins the UK and Canada in kicking off mass vaccinations after vaccine development succeeded at record speed.
Initial doses are limited and the US has already passed up a chance to book millions of additional doses of the Pfizer vaccine for the early part of 2021. Whatever is available now will go first into the arms of frontline healthcare workers and nursing home residents. Pfizer said it would have 25 million doses of the two-shot vaccine for the US by the end of December.
On Thursday after nine hours of non-stop debate, a high powered US vaccine advisory panel endorsed mass use of the Pfizer-BioNTech Covid-19 vaccine, putting the final sign-off in the hands of the US Food and Drug Administration (FDA). The FDA approval has come within 24 hours.
In a 17-4 vote, the usually obscure Vaccines and Related Biological Products Advisory Committee (VRBPAC), decided that Pfizer's shot is safe in people aged 16 and older.
Before the final vote, which came AT around 6 p.m. on Thursday, the chair of the vaccine panel boiled down the issues to a single question: "Do the benefits of the Pfizer vaccine outweigh its risks for vaccination in people aged 16 and older?" The sticking point for the last one hour was about vaccine safety in 16 and 17 year olds.
:The data is thinnest in this age group," said one of the vaccine advisory members. At least three members said they would prefer vaccinations only for people older than 18.
"The question is whether you know enough" to get the country to a safer place, said panel member Paul Offit fromf the Children's Hospital of Philadelphia. Offit voted to greenlight the vaccine. On December 17, the FDA vaccine panel will review a vaccine from Moderna and the National Institutes of Health, which has also shown over 90 per cent protection. Vaccines from Johnson & Johnson (single dose) and AstraZeneca/Oxford University are also in the pipeline. Multiple vaccines must succeed for countries to crush the virus. (IANS)
Also Watch: KMSS Protest in Guwahati