Welcome back to the third blog on US COVID-19 vaccines. Since October, two sponsors, Moderna and BioN/Pfizer, have filed for Emergency Use Authorization (EUA) in the US, the latter was approved in the UK. Though more is now known about the efficacy, which looks great so far (see chart), more will be known about short-term side effects over the next two weeks as review meetings are set to take place Dec. 10th and 17th. Data results for the three remaining agents, sponsored by Astra Zeneca, J&J, and Novavax are all expected during 1Q 2021.

Here is what is currently known, unknown, and given that, how can you self-educate?

KNOWN:

  • These vaccines will prevent cases of mild, moderate, and severe disease, and for some that become infected, they will shorten the course or lessen complications of the disease. This should result in fewer hospitalizations and less death overall.
  • The vaccines are not 100% effective; therefore, you can still get coronavirus post-vaccination, however, being vaccinated will significantly reduce the risk.
  • The virus will not be completely eradicated in 2021.
  • Most vaccines require 2 doses which means full effectiveness will not be achieved until post the second dose.
  • In the US, Pfizer has the only vaccine being studied in children as young as age 12. Outside the US, Astra Zeneca is testing AZ1222 in patients as young as 5 years of age.
  • Mechanism of Action (MOA): I like to break the vaccines into 2 categories; novel vs. proven. Those that are novel are being tested in people for the first time such as mRNA-1273 (Moderna), BNT162 (Pfizer), and Nvx-Cov2373 (Novavax). Those with a proven MOA, such as AZD1222 (Astra Zeneca) and JnJ78436735 (J&J) are utilizing technology similar to that of the Ebola virus vaccine (Zabdeno*) which was approved in the EU in July 2020. For the moment, this primarily translates to more familiarity with the substance and an existing distribution channel.
  • People who have had COVID-19 are recommended to get the vaccine.

UNKNOWN:

  • How long immunity lasts, either in people who have had Covid-19 or people who get vaccinated.
  • If the vaccine will be a one-time booster or a yearly shot.
  • If a vaccinated person can spread the virus to others.
  • Long term safety and side effects.

What can you do?

  • If you are not eligible to receive a vaccine in January or during the first month it is available, you have an opportunity to pay attention to longer term side-effects* data. Educate yourself with the longer-term safety data of clinical trial patients as well as the people who receive the vaccine early on. Seek out and follow any subgroup analysis of people taking the vaccine with conditions that may be similar to yours or family members. This could be asthma, HIV, COPD, diabetes, etc.
  • Familiarize yourself with package inserts (labeling) of prescription drugs. If you have prescription drugs at home, try reading different sections of the package insert such as Indications and Usage, Contraindications, Warnings and Precautions (and in fewer labels, Boxed Warning), Adverse Reactions, and Drug Interactions. You can even go on-line and type “Highlights of Prescribing Information” along with the prescription drug name into the URL and try reading the suggested sections on-line.
  • Refer to the chart above and make a fluid list with pros and cons regarding how the vaccines fare for you and your family. Although sub-population conditions are limited in clinical trials, they can be researched further by going to the clinicaltrials.gov records (listed in sources) and reviewing inclusion/exclusion criteria to find out if the vaccine is being tested in people with similar long-term conditions to yours or family members. I last reported that BNT162 included patients with chronic stable HIV, Hepatitis B and C.

Even though most agents are not tested in patients with underlying conditions, they are typically indicated and administered to a broad population. It is an FDA requirement to track adverse events which are then further identified, validated, possibly studied further, and then added to the label. If the side effect is serious, the FDA can impose a Risk Evaluation Mitigation Strategy (REMS*) or pull the drug from the market.

Getting vaccinated is not the end of the pandemic. Remember, you are experiencing the forefront of a new paradigm. An airborne virus is not gone overnight. As more people are vaccinated and the infection rates go down, we will be able to rejoin many pre-pandemic activities, however, all will need to continue to wear masks, social distance, get tested, participate in contact tracing, and quarantine exercises, and wash your hands for what may end up being all of 2021. Remember if you see others wearing masks at a time when many people are not, it is most likely because that person or someone they live with are compromised. If you must be within 6 feet of someone else wearing a mask, put yours on out of respect or move out of the space. It will be important that we as a nation be mindful of our more vulnerable. Consider it your gift and pay it forward.

Please post questions, comments, share your vaccine observations, and suggestions for future blogs!
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Deb Alper from Alper Consulting LLC is a strategic marketing consultant who partners with early development oncology organizations, rare disease companies, and agencies to provide commercial guidance to strategic planning, new product launch preparation, early to late phase programs, life cycle planning and target product profiles.

*Footnotes:
1 Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine | Zabdeno, European Medicines Agency
2 Side-Effects and Adverse Events terminology used interchangeably
3 REMS is a drug safety program that the US FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. They are designed to reinforce medication use behaviors and actions that support the safe use of that medication.

Abbreviations and Definitions:
BARDA: Biomedical Advanced Research & Dev. Authority, part of the Office of Assistant Secretary for Preparedness and Response at the US Dept of Health and Human Services (HHS)
EUA: Emergency Use Authorization
NIAID: National Institute of Allergy and Infectious Disease
NIH: National Institute of Health
REMS: Risk Evaluation Mitigation Strategy is a drug safety program that the US FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. They are designed to reinforce medication use behaviors and actions that support the safe use of that medication
Side-Effects and Adverse Events terminology used interchangeably

Sources:
S1 https://www.reuters.com/article/us-health-coronavirus-astrazeneca-vaccin/astrazeneca-u-s-covid-19-vaccine-trial-results-likely-in-late-jan-says-health-official-idUSKBN28C349
S2 https://clinicaltrials.gov/ct2/show/NCT04516746
S4 https://https://www.axios.com/moderna-fda-emergency-use-vaccine-4cbab802-28d6-4bf6-981b-cf27d3a06408.html
S5 https://clinicaltrials.gov/ct2/show/NCT04470427
S6 https://time.com/5914139/pfizer-covid-19-vaccine-fda-authorization/
S7 https://clinicaltrials.gov/ct2/show/NCT04368728?term=BNT162&phase=2&draw=2&rank=1
S9https://clinicaltrials.gov/ct2/show/NCT04505722?term=Ensemble&cond=Covid19&phase=2&draw=2&rank=1
S10 https://www.foxnews.com/health/johnson-johnson-expects-coronavirus-vaccine-to-be-ready-approval-feb-report
S11 https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protocol
S12 https://www.novavax.com/resources
S13 https://www.globenewswire.com/news-release/2020/11/30/2136318/0/en/Novavax-Announces-COVID-19-Vaccine-Clinical-Development-Progress.html
S14 https://clinicaltrials.gov/ct2/show/NCT04611802?term=Nvx-Cov2373&draw=2&rank=1