MarkeTouch COVID-19 Clinical and Operations Pharmacy Newsletter (March 3)

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Janssen COVID-19 Vaccine Receives EUA

The FDA has issued emergency use authorization (EUA) for the Janssen (Johnson + Johnson) COVID-19 vaccine.  The single dose (0.5 ml) injection is authorized use in individuals 18 years of age and up.  The most commonly reported side effects were; pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and appeared within 1-2 days, lasting the same 1-2 day timeframe.  

Storage of unpunctured multi-dose vials is at 2°C to 8°C (36°F to 46°F). The vaccine should be protected from light. Do not freeze the Janssen COVID-19 vaccine. Unpunctured vials of Janssen COVID-19 vaccine may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours.

After the first dose has been withdrawn from a vial, that vial can be kept between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (25°C / 77°F) for up to 2 hours. Discard the vial if the vaccine is not used within these times.

Vaccine Updates

Johnson + Johnson – A CDC epidemiologist said Monday that in the rare case where patients experience an allergic reaction to the first dose of either the Pfizer or Moderna (mRNA) vaccine they could use the Janssen vaccine, at least 28 days later, under the advise and supervision of their doctor.  CDC guidance above.

Novavax – A vaccine from Novavax could be available in the U.S. as early as May, according to their CEO, if the FDA allows data from a U.K. phase 3 trial that showed the shot had 89% efficacy.  A phase 3 trial that includes 30,000 U.S. participants is ongoing. 

Moderna – has developed a booster COVID-19 vaccine that specifically targets the South Africa variant.  Phase 1 clinical trials will begin soon.

Pfizer – FDA agreed to allow the Pfizer-BioNTech vaccine to be transported and stored for up to two weeks at conventional temperatures typically found in pharmaceutical freezers.

Should I Still Wear a Mask After Covid-19 Vaccination?

Both the Pfizer-BioNTech and Moderna vaccine do not provide significant first dose immune protection until 12 – 14 days after the first dose and they only reach 51 – 52% efficacy after a few weeks, per a December study in The New England Journal of Medicine. During this antibody building period, the body is still relatively vulnerable to COVID-19 infection. 

People will also need to be thoughtful of if and when friends and family get vaccinated until researchers are sure about the risk of COVID-19 transmission post vaccination, and a large enough portion of the population is vaccinated to achieve herd immunity. Therefore, it is the widely held recommendation that we must continue to wear masks, practice social distancing and maintain good hygiene.

CDC guidance is coming soon on safe activities for those who have received a full course of a COVID-19 vaccine.

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