Pfizer plans to seek authorization for Covid-19 vaccine in November

The first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injection. (File/AP)
Short Url
Updated 16 October 2020

Pfizer plans to seek authorization for Covid-19 vaccine in November

  • Pfizer and Modern, both funded by the US government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses
  • They aim to be in a position to deliver tens of millions of doses to the US by the end of the year

WASHINGTON: US pharmaceutical giant Pfizer expects to file for emergency use authorization for its Covid-19 vaccine in late November, around two weeks after the November 3 US presidential election, it said Friday.
The company said it hopes to move ahead with the vaccine after safety data is available in the third week of November, immediately lifting the company’s shares two percent in the US.
“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” the company’s chairman and CEO Albert Bourla said in an open letter.
The announcement means the United States could have two vaccines ready by the end of the year, with Massachussetts biotech firm Moderna aiming for November 25 to seek authorization.
The Food and Drug Administration (FDA), which authorizes pharmaceuticals for distribution in the US - asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants.
The FDA will require the vaccine to prove effective and safe, while Pfizer will have to demonstrate it is capable of producing large scale production.
Pfizer and Modern, both funded by the US government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses.
They aim to be in a position to deliver tens of millions of doses to the US by the end of the year.
Bourla said the Pfizer trial, involving 30,000 participants, might produce results on the vaccine's efficacy within the next two weeks.
"I've said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October," Bourla said.
Pfizer, which is partnering with German company BioNTech on the research, gained more than two percent in online trading ahead of the opening of US markets.


Thai protesters challenge king’s military command

Updated 14 min 16 sec ago

Thai protesters challenge king’s military command

  • Protesters accuse the monarchy of enabling decades of military domination
  • The Royal Palace has made no comment since the protests began

BANGKOK: Thai anti-government protesters challenged on Sunday King Maha Vajiralongkorn’s personal control over some army units to condemn the military’s role in politics.
It was the latest open defiance of the king by protesters, who have broken taboos by criticizing the monarchy in a country where it is officially revered under the constitution and laws to ban insulting it.
Hundreds of protesters gathered to march to the 11th Infantry Regiment, one of two units that were moved under the king’s command in 2019.
“An army should belong to the people, not the king,” Parit “Penguin” Chiwarak told reporters. “In a democratic system, the king is not responsible for directing command of the military.”
Protesters accuse the monarchy of enabling decades of military domination.
Parit is among several protest leaders who already face charges under lese majeste laws against insulting the monarchy after his speeches at previous rallies.
Protests which began in July initially demanded the departure of Prime Minister Prayuth Chan-ocha, a former junta leader, and a new constitution, but now also seek to curb the powers of the king.
At the barracks, an advance guard of protesters set about removing razor wire barricades.
The foreign ministry said in a statement that the country adhered to the rule of law, but that the right to freedom of speech must keep within it.
“In every case where the law is violated, officials take action with strict adherence to the appropriate legal processes without discrimination,” the ministry said.
Prayuth has rejected protesters’ demands that he quit along with their accusations that he engineered last year’s election to keep power that he first took from an elected government in 2014.
The Royal Palace has made no comment since the protests began, but the king has said that despite their actions the protesters are loved “all the same.”