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Pfizer Says Vaccine Is 95% Effective in Final Data, Will Seek Authorization

The positive results bring a widely available vaccine one step closer to reality.
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Final results from late-stage trials showed Pfizer’s experimental Covid-19 vaccine was 95% effective, WSJ reports.

Tell Me More: Pfizer and BioNTech, co-developers of the shot, said “out of 170 adult volunteers in the nearly 44,000-subject trial who developed Covid-19 with at least one symptom, 162 received a placebo, while eight got the vaccine” The companies plan to seek FDA approval within days, which means the shot could arrive before the year is out.

  • The vaccine appears safe and well-tolerated based on data from 8,000 study participants. Side effects included fatigue and headaches.
  • At 95%, that puts the shot “on par with shingles measles vaccines.”

The Vaccine Race: The news comes just a week after Pfizer’s preliminary analysis (which proved the shot was 90% effective) and days following Moderna’s 95% effectiveness report. Johnson & Johnson and AstraZeneca both have vaccines in late-stage testing.

Pfizer and Moderna are using game-changing technology called mRNA, a new and unproven method that “prompts cells to make a synthetic version of the spike protein that juts from the surface of the new coronavirus [and] triggers the immune system to defend against the virus.”

The FDA has a track record of approving Covid-19 treatments, authorizing emergency use on Gilead’s antiviral remdesivir and an antibody drug from Eli Lilly & Co. The regulator plans to conduct its review on vaccines more quickly than usual but plans to go by the book, starting with an independent vaccine expert committee.

Now comes the problem — getting people inoculated. Surveys say a large chunk of people are “hesitant to get the shots, partly out of concern the vaccines wouldn’t be safe because their development was rushed.” However, drugmakers and health regulators have refuted the idea that they would let a vaccine go into circulation unless it’s undoubtedly safe.

Justin Oh:

I have a call with a biotech hedge fund professional today and should have a clearer view on the Pfizer ($PFE) and Moderna ($MRNA) vaccines for tomorrow’s Live Stream. 

Pfizer’s vaccine will be shipped in 5-dose vials, yet people need 2 doses. It also needs to be stored at minus 70 degrees Celsius. Needless to say distributing Pfizer’s vaccine will be a nightmare.

Not to mention, it looks a bit shady when Pfizer’s CEO implements a stock-selling plan in August and sells $5.6 million of $PFE stock the day the company announces that its vaccine is 90% effective.

Moderna’s distribution looks easier and only has to be stored at normal freezer temperatures of minus 20 degrees Celsius. But Moderna’s vaccine is supposedly also going to be one of the most painful vaccines that we’ve seen to take.

The war on Covid-19 is not nearly over and getting people to take these vaccines will be a big challenge.

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