COVID-19 LIVE UPDATES | WHO approves Sinopharm vaccine in potential boost to COVAX pipeline
May 8 2021 09:00
AstraZeneca weighs seeking full, not emergency, US approval for Covid-19 shot
AstraZeneca Plc may skip asking the US Food and Drug Administration for emergency-use authorization for its Covid-19 vaccine and instead pursue the more time-intensive application for a full-fledged license to sell the shot, the Wall Street Journal reported on Friday.
Such a step would further delay any rollout of the British drugmaker's shots in the United States, according to the report, which cited people familiar with the matter.
Asked about the Wall Street Journal report, AstraZeneca did not comment directly, saying in an emailed statement that it "continues to progress our FDA submission for AZD1222.""It is important to note the substantial size of the file – in addition to the US trial data, the filing will also include analyses and pharmacovigilance from all studies to-date, in addition to real-world evidence data," the company added.
Last week, AstraZeneca said it was working as fast as possible to compile data on its Covid-19 vaccine to apply for US approval. The company said it planned to apply for U.S. approval in the coming weeks.
The White House said late in April that the United States would start to share up to 60 million doses of AstraZeneca's coronavirus vaccine with other countries over the next few weeks.
AstraZeneca's Covid-19 shot, developed by Oxford University, has resulted in reports of rare blood clots with low platelet levels that occur more commonly in younger adults. Some countries have advised the shot be given only to older people.
May 8 2021 09:10
WHO approves Sinopharm vaccine in potential boost to COVAX pipeline
The World Health Organization (WHO) approved for emergency use a Covid-19 vaccine from China's state-owned drugmaker Sinopharm on Friday, bolstering Beijing's push for a bigger role in inoculating the world.
The vaccine, one of two main Chinese coronavirus vaccines that have been given to hundreds of millions of people in China and elsewhere, is the first developed by a non-Western country to win WHO backing.
It is also the first time the WHO has given emergency use approval to a Chinese vaccine for any infectious disease. Earlier this week, separate WHO experts had expressed concern about the quality of data the company provided on side effects.
A WHO emergency listing is a signal to national regulators that a product is safe and effective.
May 8 2021 09:00
India posts record daily rise in Covid-19 deaths as case numbers surge
India on Saturday reported a record one-day rise in Covid-19 deaths as cases surged by more than 400,000 for the third consecutive day.
India's health ministry reported 4,187 fatalities over the past 24 hours, taking the overall death toll to just under 240,000.
Cases rose by 401,078, increasing the pandemic's total to 21.9 million