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.


At least two killed as car ploughs into pedestrian zone in German town

Updated 01 December 2020

At least two killed as car ploughs into pedestrian zone in German town

  • The driver was arrested and the vehicle was impounded, Trier police tweeted
  • Two people have died, and 15 others had suffered serious injuries

BERLIN: At least two people including a child were killed and up to 15 injured on Tuesday when a speeding car ploughed into a pedestrian area in the western German city of Trier, authorities said.
Witnesses said people screamed in panic and some were thrown into the air by the car as it crashed through the shopping zone.
Police said several people had been killed, having earlier put the death toll at two, with more than 10 injured. The local newspaper, the Trierischer Volksfreund, put the death toll at four, including a child, but police did not confirm that figure.
"We have arrested one person, one vehicle has been secured," police said, adding that a 51-year-old German suspect from the Trier area was being questioned, police said.
Mayor Wolfram Leibe had rushed to the scene.
"We have a driver who ran amok in the city. We have two dead that we are certain of and up to 15 injured, some of them with the most severe injuries," he told public broadcaster SWR.
"I just walked through the city centre and it was just horrible. There is a trainer lying on the ground, and the girl it belongs to is dead," he told a news conference, with tears stopping him from speaking further.
He told broadcaster N-TV that people who saw the incident were "totally traumatised" and the street "looks a bit like after a war".
Leibe said he did not know the motive for the incident, which shocked residents of Germany's oldest town, founded by the Romans more than 2,000 years ago.
The Trierischer Volksfreund quoted an eyewitness as saying a Range Rover was driving at high speed and people had been thrown through the air. It said the car had Trier plates.
It reported that people screamed in panic when the car drove through the street.
Officers were scouring the area in search of evidence, backed by police dressed in flak jackets and carrying rifles. On the streets, Christmas lights twinkled incongruously.
Germany has tightened security on pedestrian zones across the country since a truck attack on a Berlin Christmas market in 2016 that killed 12 people and injured dozens.
In October 2019, a man opened fire on a synagogue in the city of Halle. After failing to get into the building he went on a rampage outside, killing two people.
In February this year a racist gunman killed nine migrants in Hanau near Frankfurt before killing his mother and himself. Only about a week later, a local man ploughed his car into a carnival parade in the town of Volkmarsen, injuring 61.
Germany has tightened measures to fight the coronavirus, with bars and restaurants closed, but shops and schools are still open.
"What happened in Trier is shocking. Our thoughts are with the relatives of the victims, with the numerous injured and with everyone who is currently on duty to care for the victims," Steffen Seibert, a spokesman for Chancellor Angela Merkel, said on Twitter.