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)
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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.


Philippines military confirms death of militant leader

This photo taken on March 8, 2018 shows Philippine soldiers standing next to their armoured personnel carriers as they man a checkpoint along a highway near the clash site between government troops and militants in Datu Saudi Ampatuan town, Maguindanao province on the southern island of Mindanao. (AFP)
Updated 37 min 35 sec ago

Philippines military confirms death of militant leader

  • Abu Sayyaf leader Furuji Indama fatally wounded in clash with troops in Mindanao in early September
  • He was a close associate of the slain ASG leader Isnilon Hapilon, who in 2016 was designated Daesh emir in the Philippines

MANILA: Military authorities on Friday confirmed the death of Furuji Indama, senior leader of the Daesh-affiliated Abu Sayyaf militant group based on Basilan Island in the southern Philippines.

Indama, who was wanted over his involvement in a string of deadly bombings and kidnappings, was fatally wounded in a clash with troops in Zamboanga Sibugay province, Mindanao, on Sept. 9, along with several other fighters.

Western Mindanao Command chief Lt. Gen. Corleto Vinluan confirmed Indama’s death, adding: “We have been monitoring his family — they already know he is dead.”

Vinluan said that local officials have offered a cash reward to anyone who could pinpoint the location of Indama’s remains.

The militant leader is believed to have been buried on an island in Zamboanga Sibugay.

Vinluan said the ASG leader had sent text messages to relatives asking them to pray as he was severely wounded and “might not last long.”

The following day Indama’s cellphone “could no longer be reached.”

Idama’s death was announced following the killing of another faction member in a clash with government forces in Basilan province in the Bangsamoro Autonomous Region.

Indama was a close associate of the slain ASG leader Isnilon Hapilon, who was designated as the Daesh emir of the Philippines in 2016.

After Hapilon was killed during the 2017 siege of Marawi City, Indama was touted as a likely replacement. However, a report by the US Department of Defense later named Sulu-based ASG leader Hadjan Sawadjaan as the new acting Daesh emir.

Indama is believed to have plotted a suicide bombing at a military checkpoint in Lamitan, Basilan, that killed 11 people in 2018.

In April 2016, Hapilon and Indama led 150 Abu Sayyaf fighters in an attack on government forces in Tipo-Tipo, Basilan, killing at least 18 soldiers and wounding more than 50 others.

Indama has been wanted for his involvement in the May 2001 kidnaping of 20 people, mostly foreigners, from the affluent Dos Palmas resort in Palawan.

One of the hostages, a US national, Guillermo Sobero, was beheaded by his captors. Officials said the ASG leader’s death is expected to leave the militant group in disarray. Many members have recently surrendered to government forces.

In July, the military said that Sawadjaan had been killed, but his death remains unconfirmed.