Your Coronavirus Update for December 16, 2020

By: Joe Darrah

Your Coronavirus Update for December 16; stay up to date with Elite.

More than 72.6 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including at least 1.62 million deaths. Healthcare officials in the United States have reported more than 16.5 million positive COVID-19 cases and at least 300,000 deaths. Source: Johns Hopkins University & Medicine

Pfizer & BioNTech Earn Vaccine Administration Approval

The Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine for individuals 16 years of age or older in the United States. Pfizer and BioNTech will reportedly gather additional data and prepare to file a planned Biologics License Application with the FDA for a possible full regulatory approval in 2021.

The Department of Defense and the Department of Health and Human Services, including the Centers for Disease Control and Prevention (CDC), will reportedly manage allocation and distribution of the vaccine. Prioritization will occur according to the populations identified by the CDC’s Advisory Committee on Immunization Practices guidelines, officials said on Dec. 11.

“As a U.S. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic,” said Albert Bourla, chairman and chief executive officer at Pfizer, in a prepared statement. “We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.”

The FDA reportedly based its decision on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study announced in November. The Phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior infection (first primary objective) and in participants with and without prior infection (second primary objective), in each case measured from seven days after the second dose. The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine, officials said. Efficacy was consistent across age, gender, race, and ethnicity demographics. All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose.

More Americans Willing To Receive Vaccine, Survey Shows

Approximately 60% of people surveyed in the United States are now in favor of being administered the COVID-19 vaccine. According to a recent report by Pew Research Center,1 nearly half of those surveyed who still remain reluctant to be inoculated do say they will be more likely to do so after they see that others have received it. 

The research also found that a majority of Americans still remain uncomfortable about the though of “being among the first to take [the vaccine]” while many plan to pass on their opportunity when it comes.
The findings come after preliminary analysis from two clinical trials has produced vaccines that are reportedly 90% effective. Other findings from the survey include:

  • 75% of respondents have at least a fair amount of confidence in the development process, compared with 65% in September.
  • 54% of Americans say they know someone personally who has been hospitalized or died due to the coronavirus. 
  • Among Black Americans, 71% know someone who has been hospitalized or died because of COVID-19.

Reasons for getting a vaccine include:

  • Personal concern about getting a case of COVID-19 that would require hospitalization.
  • Trust in the vaccine development. 
  • Personal practices when it comes to receiving other vaccines. 

The survey was conducted Nov. 18-29 among more than 12,000 U.S. adults.

FDA Issus Vaccine Avoidance Guidelines

Healthcare providers are being alerted by officials with the Food and Drug Administration (FDA) to not administer the newly distributed COVID-19 vaccine to patients under certain conditions:

  1. If the patient has had a severe allergic reaction to any ingredient of the vaccine – mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
  2. If the patient previously experienced an allergic reaction to the vaccine.
  3. If the patient has any allergies.
  4. If the patient has a fever.
  5. If the patient has a bleeding disorder or is on a blood thinner.
  6. If the patient is immunocompromised or on a medicine that affects the immune system.
  7. If the patient is pregnant or plans to become pregnant.
  8. If the patient is breastfeeding.
  9. If the patient has already received another COVID-19 vaccine.

References

1. Funk C, Tyson A. Intent to Get a COVID-19 Vaccine Rises to 60% as Confidence in Research and Development Process Increases. Pew Research Center. 2020. Accessed online: www.pewresearch.org/science/2020/12/03/intent-to-get-a-covid-19-vaccine-rises-to-60-as-confidence-in-research-and-development-process-increases

 

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About The Author

Joe Darrah is a freelance author based in the Philadelphia region who has been covering the healthcare field since 2004. He may be reached at [email protected] Lawrence F. Kobak is senior counsel in the healthcare department at Frier Levitt, a national boutique healthcare law firm based in Uniondale, NY, that provides comprehensive regulatory, transactional, and litigation counsel to the healthcare and life sciences industries. He may be reached at [email protected]