Pfizer to seek emergency approval for COVID vaccine next month

10/17/2020 03:00 | 1

Based on current trial enrollment and dosing pace, Pfizer expects to have that safety data in the third week of November, Chief Executive Officer Albert Bourla said in a statement.

Bourla estimated that Pfizer's 44,000-person study would reach that milestone in the third week of November.

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.

Though President Trump and others have portrayed it as a silver bullet in bringing the rampaging deadly virus to an end, epidemiologists and vaccine researchers tend to portray any COVID-19 vaccine more as one effective tool among many in the fight against the spread of the disease.

Without further data on how effective the vaccine is and how long immunity from it may last, it's also hard to know what impact any of the shots now in phase III trials will have on controlling the pandemic.

The Bourla letter released Friday confirmed a time line laid out by BioNTech CEO Ugur Sahin this week. During a digital event in September, he also said the company expected initial results in late October and would seek FDA authorization as soon as possible.

The plan also prioritizes which groups will receive the vaccine first, although at this point it's unknown how long it would take to move through each of the four phases. AstraZeneca's USA trial has been on hold since September.

Moderna is only slightly behind Pfizer, and has said it could get preliminary efficacy data by late November.

The first batch of Russia's Sputnik-V vaccine against the novel coronavirus was delivered to Venezuela in early October, and 2,000 volunteers have been selected to participate in the trials.

On Tuesday, pharmaceutical company Eli Lilly said it paused a government-sponsored antibody treatment trial because of a "potential safety concern".

The platform used for the vaccine was developed by Russian scientists over 20 years and had formed the basis for several vaccines in the past, including those against Ebola.

The first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore received an injection in May. Even if that were so, a pre-election vaccine would mean the Food and Drug Administration would have to give an nearly immediate thumbs-up.

The coronavirus vaccine will be free for all Americans, but initially the COVID-19 vaccine will likely be available to higher-risk groups, such as health care workers, essential workers, the elderly, and those with health conditions that make them more vulnerable to COVID-19.

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