Pfizer Inc says it could have results from its late-stage coronavirus vaccine trial available as early as October.
On Thursday, CEO Albert Bourla said during a call sponsored by drug industry group International Federation of Pharmaceutical Manufacturers & Associations that 23,000 volunteers have been enrolled in the phase III trial, which began in July.
The New York-based drug company says if data shows the jab is safe and effective, it will submit an application for approval, along with its German partner BioNTech, immediately.
‘We expect by the end of October, we should have enough…to say whether the product works or not,’ Bourla said.
Pfizer is in a race with companies such as AstraZeneca Plc, Johnson & Johnson, Moderna and Sanofi to produce a vaccine as President Donald Trump pledged his administration could have an inoculation before the November 3 election.
However, the White House fervently denied that anyone from the Trump administration is putting political pressure on the US Food and Drug Administration to approve a vaccine.
Pfizer Inc has enrolled 23,000 people in phase III of its coronavirus vaccine trial, which began in July. Pictured: The first patient enrolled in Pfizer’s coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection, May 2020
If the vaccine is shown to be safe and effective, CEO Albert Bourla says the company will apply for approval immediately. Pictured: Pfizer headquarters in New York City, July 2019
The vaccine candidate from Pfizer and BioNTech uses part of the pathogen’s genetic code called messenger RNA, or mRNa.
It trains the body to recognize the coronavirus, which will send out an immune response if a person becomes infected.
In July, the company released data from its early-stage trial, involving 45 people who received either a low, medium or high dose of the vaccine in two shots or a placebo.
Volunteers given either the low or medium dose generated not just antibodies against the virus but specifically neutralizing antibodies, meaning they stop the virus from infecting human cells.
Results showed the levels of neutralizing antibodies were between 1.8 and 2.8 times greater than those seen in recovered patients.
Pfizer says it hopes to enroll up to 30,000 participants. The trial is expected to take place at 120 sites across the world, including 39 US states.
In July, the US government signed a $1.95 billion-deal with Pfizer in exchange for 100 million doses of its immunization.
The agreement was part of Operation Warp Speed, the Trump administration’s plan to fast-track coronavirus vaccine candidates in America.
Pfizer says it plans to supply 100 million doses by the end of 2020 and about 1.3 billion doses by the end of 2021.
Dr Anthony Fauci, the nation’s top infectious disease expert, said it is possible a vaccine ready by the end of October, but that he is not counting on it.
‘These are all guesstimates,’ Fauci told CNN when asked about Pfizer’s plans, adding that most believe an inoculation will be ready by November or December.
‘It is conceivable that you can have it by October, though I don’t think that that’s likely.’
It comes as the Centers for Disease Control and Prevention told states to prepare to distribute a vaccine as soon as November and White House Spokeswoman Kayleigh McEnany said there is no political pressure on the FDA to quickly approve a coronavirus immunization.
This has made public health experts worry that Trump is pressuring regulators to get a jab on the market before there is enough data to review.
However, Pfizer says its will not submit an application for approval if the results don’t prove the vaccine is safe and effective.
‘We will never ourselves submit for authorization or approval any vaccine before we feel it is safe and effective,’ Bourla said.
‘We will not cut corners. Our phase three study will be the only one that will allow us to say if we have a safe and effective vaccine. If we don’t have results from a phase three study, we would not submit.’
Link nguồn : https://www.dailymail.co.uk/health/article-8695209/Pfizer-expects-results-coronavirus-vaccine-trials-October-CEO-confirms.html
