409 - COVID-19 Vaccine in Adolescents, COVID-19 Vaccine Update

From the FDA, CDC, and Question from a Colleague

1) COVID-19 Vaccination in Adolescents

Question: “Given the limited data on the COVID-19 vaccine in children and adolescents, what are you recommending for your patients?”

Answer: Currently, only the Pfizer/BioNTech COVID-19 mRNA vaccine is authorized by the FDA under the emergency use provisions for patients below 18 years old. To expand their initial Emergency Use Authorization (EUA) (for ages 16+), Pfizer submitted effectiveness data from the interim results of a single clinical trial in adolescents (age 12-15) of the mRNA vaccine vs. placebo.

First, an analysis done 7 days after the second vaccination of 1983 adolescents showed no COVID-19 disease in the vaccine group and 16 cases in the placebo group. No data was presented about hospitalization, multisystem inflammatory syndrome (MIS-C) or other complications. In addition, immunogenicity (antibody) data was compared between a group of 190 adolescents (age 12-15) and a group of young adults (age 16-25) and was found to be non-inferior (statistically at least as good).

The full cohort from this study was analyzed for at least 2 months for the safety data presented to the FDA. The typical vaccine-related reactions (headache, fever, site reaction, etc.) were reported in ~91% of recipients. These lasted for 1-3 days and were a little worse with the second dose. Severe reactions (“interfering with daily activity”) were reported in ~11% of patients. Serious adverse events were reported less than 1% of the time, and none were felt to be vaccine related.

Based on the efficacy and safety data, the ACIP, while acknowledging the limitations of the data, recommended COVID-19 vaccination with the Pfizer vaccine for patients age 12 and older based on the predicted public health benefit outweighing the harms.

Recently, instances of myocarditis and pericarditis have been reported primarily in young men age 12-29. These cases are rare, generally clinically mild and respond well to simple treatments. For one million males age 12-29 getting their second dose of vaccine, we can expect 37-41 cases of myocarditis, but we prevent 11,000 cases of COVID-19 and 6 deaths. It should be noted that the myocarditis incidence in children who contract COVID-19 is as high as 3%.

Syncope can occur in adolescents getting any vaccine, and this has been reported for COVID-19 vaccination also. Take measures to prevent falling/injury, and observe patients for 15 minutes, having them seated or lying down if fainting is a concern.

John’s Comments:

At least 20% of the population is under age 16, so we must expand vaccination to these age groups if we want to get control of the pandemic. The ACIP noted that COVID-19 among adolescents is a significant public health problem and they are responsible for a sizable amount of in-home transmission. I will encourage my patients age 12 and up to get the vaccine. I will watch for any signs of myocarditis/pericarditis (chest pain, shortness of breath, palpitations, etc.) and work them up carefully, making sure to involve a cardiologist. Advise your patients receiving COVID-19 vaccination to enroll in V-Safe, the CDC’s vaccine monitoring service, and make sure to report any adverse events to VAERS (http://vaers.hhs.gov)

References:

• FDA. Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic [Internet]. FDA. FDA; 2021 [cited 2021 Jul 26]. Link
• Wallace M. The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12–15 Years — US, May 2021. MMWR. 2021 [cited 2021 Jul 26];70. Link
• Gargano JW. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the ACIP — United States, June 2021. MMWR Morb Mortal Wkly Rep [Internet]. 2021 [cited 2021 Jul 26];70. Link

From the CDC

2) COVID-19 Vaccine Review Update

Since clinics in our area are getting COVID-19 vaccines to distribute to their patients, we felt it was timely to review the current vaccine guidance for all of our readers:

• Pfizer/BioNTech vaccine
  • Emergency Use Authorization (EUA) for 12 years of age and up (see Pointer 1 about the EUA for adolescents)
  • Two 0.3 ml doses, three weeks apart
• Moderna vaccine
  • EUA for ages 18 and older
  • Two 0.5 ml doses, four weeks apart
• Janssen/Johnson & Johnson vaccine
  • EUA for ages 18 and older
  • Single 0.5 ml dose
• Interchangeability
  • Stick with one product for vaccination if possible – there is no data on how well they work when doses are mixed.
  • When the mRNA product used for the first vaccine cannot be obtained for more than 6 weeks you can use the other for the second dose. These patients are considered fully vaccinated.
  • If no mRNA vaccine can be obtained for the second dose, you can give the Janssen vaccine 28 days after the initial mRNA vaccine. This would be counted as a single-dose Janssen vaccine only (not a mixed-dose).
• Co-administration
  • All COVID-19 vaccines may now be administered with other vaccinations without regard to timing.
  • It is best to give injections in different sites, separated by 1 inch or more. Try to give vaccines likely to cause local reactions (Td, adjuvanted vaccines, COVID-19 vaccines) in different limbs if possible.
• People vaccinated outside the US
  • Anyone with documentation of all recommended doses of a World Health Organization (WHO)-authorized vaccine is fully vaccinated.
  • Anyone else (partially vaccinated, no documentation, non-WHO-authorized vaccine) should have a full series of an FDA-authorized vaccine.
• Booster doses
  • No official recommendations yet. Stay tuned.
• Contraindications
  • History of a severe allergic reaction (including anaphylaxis) to any component of the vaccine is a contraindication.
  • Patients with a history of allergy to components in the mRNA vaccines may be able to get the Janssen vaccine, and vice-versa – it is best to consult an allergist in these cases and ensure that the vaccine is administered in a facility capable of managing severe allergic reactions.
• Not contraindications
  • Patients with a history of Guillain-Barre syndrome, who are immune compromised, or who have autoimmune disorders all may receive the vaccine.
• Thrombocytopenia syndrome (TTS) after Janssen vaccine
  • Warning for women <50 years about the rare possibility of TTS. They should be advised of the availability of other vaccines.
  • If a patient gets shortness of breath, chest pain, leg swelling, persistent abdominal pain, severe headaches, blurred vision, or easy bruising within 3 weeks of vaccination – they should be evaluated for TTS.
  • A history of clotting disorder of venous thromboembolism does not exclude patients from receiving the vaccine unless the disorder is known to be immune-mediated (e.g., heparin-induced thrombocytopenia) and it has been less than 90 days since the episode. It may be best to consult with a hematologist if there are questions.
• Myocarditis/pericarditis after mRNA vaccines (See Pointer 1 in this issue).
  • Usually in males aged 12-29, within a few days after 2^nd dose of vaccine.
  • 1226 reports (out of over 52 million doses) in this age group in the seven months prior to June 2021.
  • In a subset of these reviewed, most were mild cases, no deaths, and generally responded to NSAIDs.
  • Review of benefit/harm information suggests vaccination was overwhelmingly beneficial in the adolescent/young adult male population despite the incidence of myocarditis/pericarditis.
• History of COVID-19 disease
  • All otherwise eligible patients should be offered vaccination, regardless of history of COVID-19.
  • Patients should have recovered from the acute illness and met criteria for discontinuing isolation, but there is no other recommended interval between illness and vaccination.
  • There is some evidence that COVID-19 re-infection risk is low in the few months immediately after infection but increases with time.
  • Patient with a history of Multisystem Inflammatory Syndrome (adults or children) may get vaccinated, but there is little evidence about safety or effectiveness. Waiting 90 days after recovery from this syndrome is prudent, and consultation with a specialist is recommended.
  • Patients having received monoclonal antibody therapy or convalescent serum therapy should wait 90 days to get vaccinated. Other immunoglobulin therapy is unlikely to affect immunization.

John’s Comments:

We are a proven, trusted source of information for our patients concerning these vaccines, so making sure we have all the facts as they are known today is important. Bookmark the link in the references for an up-to-date source of this information. A very nice 2-pager document suitable for posting in your office is found here.

Reference:

• Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC [Internet]. 2021 [cited 2021 Jul 26]. Link

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Mark and John

Carilion Clinic Department of Family and Community Medicine

Feel free to forward Take 3 to your colleagues. Glad to add them to the distribution list.

Email: mhgreenawald@carilionclinic.org