Saturday, December 12, 2020

About the Pfizer BioNTech COVID-19 Vaccine trial

Important things we know about the Pfizer BioNTech COVID-19 Vaccine

• From roughly 44000 participants, vaccine and placebo were administered 1:1 ratio, the vaccine participants demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose.

• Partial protection from the vaccine candidate appeared as early as 12 days after the first dose.

• The vaccine has shown consistent results in people of different ages, races, BMI, and with various co-morbid conditions.

About the trial:
Pfizer conducted a randomized, observer-blinded COVID-19 vaccine trial for an mRNA vaccine named BNT162b2. The vaccine trial recipients will be followed up for two years to track antibody longevity and long-term side effects of the vaccine. The vaccine is dosed at a two-week interval. There are in total 6 visits and at the first two visits the vaccine was administered and blood is collected to check serum for preformed antibodies and the rest 4 visits are spaced at 4 weeks, 6 months, 1 year, and 2 years from the first dose, here only blood is collected to monitor serum antibodies. 

The people enrolled in the trial have to maintain a digital diary of the symptoms. There are roughly 44000 people who have registered for the vaccine and various modifications were made to the trial as it kept increasing the study population such as including people below 16 years of age, representing minorities including African American, Hispanics, Native Americans, etc. Another update was to include people with Hepatitis B, Hepatitis C, obesity, and some other co-morbid conditions. The vaccine had uniform tolerability and efficacy in such a varied population.

How did they calculate 95 percent efficacy?
There were 36,523 participants and 170 cases of COVID-19 onset were observed at least 7 days after the second dose, 8 cases were from the vaccine group and 162 from the placebo group, corresponding to the 95 percent vaccine efficacy (CI 90.3-97.6).

The vaccine efficacy between the first and second doses is 54 percent (CI 29.5 -68.4).

Common Side effects and storage requirements:
Amongst the side effects of the vaccine most common ones are pain at the injection site, fatigue, and headache. There is not enough data for the safety of the vaccine in pregnancy and excretion in breast milk.

The vaccine vial has to be stored at -70 degree Celsius and during administration, it has to be thawed at room temperature for 30 mins, diluted and then administered. Once the diluted vaccine dosage is made it can be stored for 6 hours in a refrigerator at 2-8 degrees Celsius.

Written by Tasneem Adenwala

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