Pfizer Inc expects to provide safety data and file for authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, delaying any clarity on the vaccine until after the Nov. 3 USA presidential election.
Two American companies expect to apply for emergency approval for their Covid-19 vaccines by late November, welcome news as the U.S. hits a third surge of its coronavirus epidemic and approaches its eight millionth case.
"Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November", Bourla wrote.
For months, Pfizer CEO Albert Bourla had maintained that the company would know this month whether its BioNTech-shared COVID-19 vaccine works.
Pfizer's comments on its time line raise the possibility of USA authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy. The timelines included in the letter are not new, based on disclosures the company has previously made about the status of its vaccine effort with the German biotechnology firm BioNTech.
Russian Federation has also promoted its Sputnik V vaccine overseas, despite concerns about its effectiveness and safety.
Putin said that Deputy Prime Minister Tatyana Golikova and the head of Russia's consumer safety watchdog Anna Popova have both received the EpiVacCorona vaccine as part of clinical trials.
Despite President Donald Trump's repeated promises of a vaccine before Election Day, scientists had been cautioning that it's unlikely data showing a leading shot actually works would come until November or December.
The cold chain network which the hospital created can deliver the vaccine in less than 30 mins and in maximum 48 hours across the country. This could mean that the study will continue, with half the patients receiving placebo, after it is known that the vaccine is effective.
The registered vaccine, EpiVacCorona, was developed at a research centre in the Siberian city Novosibirsk, said Putin. AstraZeneca's USA trial has been on hold since September.
"We need to increase production of the first and second vaccine". 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 finding published on Thursday is similar to that released in August by Translate Bio, which at the time said it aimed to launch clinical trials in November. Another U.S. trial of a candidate from Johnson & Johnson JNJ.N was paused earlier this week.