COVID-19 Vaccine Development and the Pharmacist’s Role

In the United States, new cases of COVID-19 have been on the rise with daily numbers ranging between 50,000 and 60,000 since late June. Predictions are showing a larger spike in new cases through mid-August.  Luckily, while numbers continue to surge, so do efforts to develop a vaccine.

As the United States’ leading expert on infectious disease, Dr. Anthony Fauci and his team have plans for a large clinical trial involving approximately 30,000 participants that will be underway later this month. This large-scale study would help determine if the vaccine they have been developing with the National Institute of Health and Moderna Inc. has potential to shield against COVID-19. For this vaccine to be effective it must induce T-cells to create memory cells, as well as specialized T-cells that activate B-cells to produce the appropriate antibodies to tag or neutralize the virus for elimination. Additionally, Oxford and AstraZeneca have been working together on a vaccine currently in the Phase III clinical trial. Data on immunity and safety for this vaccine is expected August 2020. Globally, with hundreds of vaccines under development and testing, the possibility of seeing one soon may no longer be just wishful thinking.

However, initial trials for both vaccines have shown concerning signs of side effects. The Phase I and 2 results for Moderna’s vaccine showed signs of chills, headaches, and fatigue appeared in participants after the second dose. Oxford’s initial trials showed that about a third of participants had moderate to severe side effects including muscle aches, chills, low grade fever, headache, malaise, and fatigue. Currently, participants for Oxford’s vaccine in the Phase III trial are given acetaminophen along with the vaccine; possibly to reduce the side effects already seen in previous trials. Once on the market, side effects will be a large concern and pharmacists should be prepared to help with side effect management for those getting the vaccine.

The limiting factor could be the vials and syringes needed for the vaccines. Current supplies will not meet the demands of approximately 6 billion people globally who will require vaccination to obtain “herd immunity.” With rising demands, governments and pharmaceutical companies around the world are contracting with multiple manufacturers in hopes of producing enough vials once vaccines are launched. In the US, the Trump administration has contracted with domestic manufacturers; some of which produce their products in Asia or Europe. Some of the companies include Corning, a US glass maker; BD, a worldwide medical supply company; Retractable Technologies, a company in Texas that produces syringes; and ApiJect Systems, a company that makes prefilled syringes. To push demands even further, most vaccines under trial require two doses to be administered. If this is the case with the final vaccines, pharmacists will need to track the patients first and when the second dose is needed. In addition, pharmacists should know the CDC expects 10 ml vials holding 8 to 15 doses to be the standard once vaccines are available.

As of 2019, 46 states, as well as D.C. and Puerto Rico, have given authority for pharmacists to administer any type of adult vaccinations. The remaining 4 states; New Hampshire, New York, West Virginia, and Wyoming; have limitations on what immunizations pharmacist can administer. This progress in public health has allowed easier and quicker access to immunization for the public and will be essential in the context of a possible COVID-19 vaccine. Pharmacists should not only be prepared to administer vaccinations once available, but also provide education on the topic.  Staying informed about the latest developments on COVID-19 and the vaccines in progress will help prepare pharmacists for any questions or concerns that their patients may have. Once a vaccine is developed, pharmacists should discuss with patients that a vaccine is not a cure but rather a preventative measure. Providing written materials and verbal counseling discussing potential side effects and risks associated with the vaccine will further patient education. In addition, pharmacists will need to discuss methods of side effect management with patients. Pharmacists will prove to be a valuable resource in the fight against COVID-19.

References

  1. John Hopkins. COVID-19 United States Cases. https://coronavirus.jhu.edu/us-map. (Accessed 2020 July 17).
  2. Neergaard L. First COVID-19 vaccine tested in US poised for final testing. AP News. https://apnews.com/e4d5259bfc6c74fcb090d885737c55a6. (Accessed 2020 July 17).
  3. Early-Stage Trial Data on AstraZeneca COVID-19 Vaccine Due Monday – Lancet. U.S.News. 2020. https://www.usnews.com/news/top-news/articles/2020-07-15/positive-news-on-oxford-astrazeneca-covid-19-vaccine-could-come-on-thursday-itv. (Accessed 2020 July 17).
  4. Bastian H. Covid-19 vaccines with ‘minor side effects’ could still be pretty bad. 2020. https://www.wired.com/story/covid-19-vaccines-with-minor-side-effects-could-still-be-pretty-bad/ (Accessed 2020 Aug 3).
  5. Rowland C. A race is on to make enough small glass vials to deliver coronavirus vaccine around the world. The Washington Post. (July 2020).
  6. APhA/NASPA. Pharmacist Administered Vaccines. (January 2019). https://naspa.us/wp-content/uploads/2019/04/IZ-Authority-012019.pdf. (Accessed 2020 July 17).

 

Posted August 2020

2 responses to “COVID-19 Vaccine Development and the Pharmacist’s Role”

  1. Kyle Spaniol says:

    I fully agree that pharmacists will have an important role in the fight against Covid-19. A very well-written article.

    • Alan Sekula says:

      Kyle,

      Thanks for reading our blog and providing your comment! Another interesting twist is the coverage by Medicare Part B for COVID-19 Vaccines. This will exclude pharmacists from being paid to administer the vaccine. Pharmacy organizations are advocating for a change but it until the change is made, pharmacists may have their hands tied for this segment of the population.

      We encourage you to keep reading our posts and please don’t hesitate to send further questions or comments.

      Thanks again,
      The PHSL Team

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