NEW DELHI (DIVYA SAINI): Pfizer's vaccine for covid-19 is "very close" to applying for an emergency Authorization after collecting safety data to submit to US regulators, the company's CEO said on Tuesday. Last week, Pfizer and its partner BioNTech said that an interim analysis showed their experimental vaccine was more than 90% effective in preventing symptomatic cases of Covid-19.
" On Tuesday, Bourla said that a key safety milestone had been reached in the study of its Covid-19 vaccine. Speaking at a virtual conference hosted by the New York Times, Bourla said the company was preparing to submit its data to the U.S. Food and Drug Administration (FDA). “We are preparing now for submissions," Bourla said
The Food and Drug Administrator (FDA) had imposed a requirement on Covid-19 vaccine makers of having at least two months of follow-up with volunteers after their second dose, taken 28 days after the first, in order to ensure the drugs are safe. Pfizer and BioNTech said they planned to request an Emergency Use Authorization (EUA) soon after they collected the required safety data.
On Monday, another candidate of vaccine, Moderna and the US National Institutes for Health announced similar results from trial, finding their vaccine almost 95% effective. Moderna has previously said it expects to apply for an emergency use authorization by November 25. In India, there are five COVID-19 vaccine candidates under various stages of clinical trials of which two are in the third phase.
“We are very close to submitting for an emergency use authorization,” said Albert Bourla “We will announce it as soon as we are doing it”.
Bourla added that ‘Pfizer would soon release more detailed efficacy results’. He also added ‘we welcomed Moderna's announcement and hopes other companies development efforts are successful, so as to meet the urgent need for safe and effective vaccines worldwide’.
Image Credits: Google