Pfizer won't seek Covid-19 vaccine approval before mid-November

PH panel OKs Chinese vaccine for clinical trial — FDA – The Manila Times

Philippines eyes Sinovac trial as early as November

Pfizer won't apply for FDA emergency use authorization before the third week of November, Bourla wrote in an open letter on Friday.

The Food and Drug Administration (FDA), which authorizes pharmaceuticals for distribution in the United States - asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants.

- Pfizer and BioNTech will have two months of safety data on half the patients in their 44,000-patient vaccine study in the third week of November, based on current enrollment rates.

For months, Pfizer CEO Albert Bourla had maintained that the company would know this month whether its BioNTech-shared COVID-19 vaccine works.

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And that there is an alternative to engaging in that kind of stuff so I would just say to be very conscious and responsible. I think that is as simple as it comes and as necessary as it comes. "You have the power to turn this around".


Russian Federation has approved its second coronavirus vaccine, President Vladimir Putin announced Wednesday as the peptide-based shot developed by a Siberian biotech company readies for large-scale trials.

"As far as I know, we already have a third vaccine in development", he added, which is now being tested at the Chumakov research centre of the Russian Academy of Sciences.

Russian Federation has also promoted its Sputnik V vaccine overseas, despite concerns about its effectiveness and safety.

The Food and Drug Administration (FDA) expects to receive the Chinese drug maker's formal application for phase three clinical trials within two weeks and regulators will make a decision after their evaluation, FDA head Rolando Enrique Domingo said. This would allow the companies to file for an emergency use authorization.

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When and how that changes upon Saban's contraction of COVID-19 remains to be seen. "I immediately left work and isolated at home. Sarkisian previously served as the Washington Huskies and USC Trojans head coach.


That's a clear shift from Bourla's previous comments, which constantly featured "October" as the key word-at a time when President Donald Trump was touting a vaccine before the November 3 election, and mentioning Pfizer by name.

The eastern city of Jiaxin's center for disease control and prevention (CDC) said in a statement on WeChat that two doses of the vaccine candidate, called CoronaVac, will cost 200 yuan (RM 124) per dose and that vaccinations for key groups including medical professionals have begun.

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. That trial remains on hold in the U.S.

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.

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De quoi altérer sérieusement les chances du MHSC face à Monaco ce week-end. Il s'agit de huit joueurs et quatre membres du staff testés positifs.


In July, the U.S. Department of Health and Human Services and the Department of Defense (DoD) announced an agreement with Pfizer for an initial order of 100 million doses of a coronavirus vaccine for the price of $1.95 billion, following EUA or licensure.

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