Pfizer has enough data to request emergency use of vaccine

By: Lynn Desjardins
The pharmaceutical companies Pfizer and BioNTech are now announcing new test results that show their vaccine against COVID-19 is 95 per cent effective and they will to go to U.S. authorities to ask for emergency approval for use.
The U.S. FDA can issue an Emergency Use Authorization to allow unapproved medical products to be used during a public health emergency when there are no approved alternatives and the evidence shows it is reasonable to believe the product is effective.
The test involved 44,000 people in the U.S. and five other countries and was found to be effective across age, race and ethnicity demographics, and was well tolerated. Only four per cent said they felt fatigue after the second dose.

50 million doses possible before end 2020

The companies say they have ramped up manufacturing capabilities around the world. They expect to be able to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
The vaccine must be kept at extremely low temperatures, but the companies say they have developed specially designed thermal shippers. These, they say, can be used as temporary storage units for 15 day by refilling with dry ice. The shippers contain thermal sensors to track the location and temperature of each vaccine shipment.
Because of the novel way the vaccine is made, Pfizer says it can be modified if the virus mutates.
Last week, Moderna announced that its experimental vaccine seems to be 94.5 per cent effective after it analysed its late-stage study. Its vaccine does not require storage at temperatures as low as the Pfizer vaccine.
Canada has agreements to purchase both vaccines once they are ready to be rolled out. Each country will decide who gets the vaccine first, but Pfizer suggests it will be front line health care workers, essential workers, immunocompromised individuals and those in nursing homes.