Pfizer Vaccine on Track for Regulatory Review in October

Pfizer-J J-Biosimilar

The Muslim Times has the best collection of articles for the war against Covid 19, especially the vaccines.

Source: Bloomberg

Pfizer Inc. and BioNTech SE said the Covid-19 vaccine they are jointly developing is on track to be submitted for regulatory review as early as October, as they released additional data from an early-stage study.

The companies said the vaccine was well tolerated with mild to moderate fever in fewer than 20% of the participants. The companies are continuing to analyze data from the Phase 1 trials in the U.S. and Germany, they said in a statement.

The confirmation of their October goal, first announced last month, helped lift S&P 500 futures briefly on Friday as part of a drumbeat of positive news on inoculation efforts that have the potential to end the threat of damaging lockdowns.

The timeline would make the vaccine one of the fastest-moving in the world. Some analysts expect a vaccine to be approved for use by November in the U.S., a move which may give President Donald Trump a new foothold in the election.

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In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.

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Categories: Vaccine

3 replies

  1. Vaccine frontrunners in China have shipped their shots to virus hotspots around the world like Brazil, Indonesia and Saudi Arabia to conduct final-stage trials. State-owned drugmaker Sinopharm Group Co. said this week that the two inactivated vaccines developed by the company’s subsidiaries will be available as soon as the end of the year and will be priced at less than 1,000 yuan ($145) for two doses. Beijing-based vaccine maker Sinovac Biotech Ltd. expects its shot to win regulatory approval early next year.

    https://www.bloomberg.com/news/articles/2020-08-21/pfizer-virus-vaccine-on-track-for-regulatory-review-in-october?sref=eGA8az79

  2. Despite rumors to the contrary, AstraZeneca (NYSE:AZN) says it has held no talks with the U.S. government about emergency use authorization of its COVID-19 vaccine, currently dubbed AZD1222.

    Yesterday, The Financial Times reported that the Trump administration was mulling a plan to do just that if data from a 10K-subject UK study are positive. Preliminary results should be available next month.

    The FDA has stated that an approval of any COVID-19 vaccine will need to be supported by data from a trial involving at least 30K people. AZN is launching such a study in the U.S. but results may not be available until after the November 3rd election.

    At a press conference yesterday to announce emergency use authorization of convalescent plasma for the respiratory infection, President Trump hinted that a similar nod for a vaccine might be imminent.

    Leading Democrats say the White House must not approve a vaccine without sufficient data to support approval. FDA division chief Peter Marks, whose group oversees vaccine approvals, told Reuters that he will resign if the Trump administration pressures the agency to approve a vaccine without adequate data showing its safety and effectiveness.

    Other vaccine developers at the head of the pack include Moderna (NASDAQ:MRNA), who expects to complete enrollment in its large-scale trial by the end of next month, and Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) who have recruited about 1/3 of the planned participants in their study and have stated that their candidate, BNT162b2, will be ready for regulatory review in October.

    https://seekingalpha.com/news/3608120-astrazeneca-up-4-on-rumored-fast-track-approval-of-covidminus-19-vaccine-in-u-s

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