With input from Dr Monica Vasudev
- The US CDC advisory committee has recommended the recently authorized Pfizer-BioNTech COVID-19 vaccine for individuals aged 16 and above in the United States, and stated that it has been found to be safe and effective.
- ACIP voted 11-0, with three recusals, to recommend the use of Pfizer-BioNTech mRNA vaccine in individuals aged 16 years or older.
- The panel voted to include the vaccine in 2021 immunization schedules. The panel members stated that the recommendation should go hand-in-hand with ACIPs prior recommendation on December 1 that allocation of the vaccine be phased-in, with healthcare workers and residents and staff of long-term care facilities in phase 1a.
- The panel said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, immunocompromised, or those who have a history of allergies.
- The FDA healthcare provider information sheet stated that there is insufficient data to recommend vaccinating those women or the immunocompromised, and also advised against vaccinating the individuals who have a history of serious allergic reaction to any component of the vaccine.
- Peter Marks, MD, PhD, director of the FDAs Center for Biologic Evaluation and Research (CBER) clarified this in a briefing on December 12, stating that pregnant or lactating women can make the decision in consultation with their physician. He added that patients with any other history of allergy should be able to safely get the vaccine.
- For any woman considering vaccination, she must consider the level of COVID-19 in the community, her personal risk of contracting the virus, the risks to her or her fetus of developing the disease, and the vaccines known side effects.
- On the potential for allergic reactions, the CDC agreed with the FDA that the vaccine should not be given to those with a history of serious reactions. This should include those who have had a reaction to any vaccine or injectable drug product as injectables may contain the same ingredients as the Pfizer vaccine.
- The CDC will urge clinicians to observe patients with a history of anaphylaxisfor 30 minutes following vaccination and all patients for at least 15 minutes.
- One ACIP panel member, Henry Bernstein, DO, MHCM, FAAP, stated that he was concerned that supporting the use of the vaccine in 16- and 17-year-olds was a leap of faith, provided that there was extremely limited data on this cohort. Bernstein added that systemic reactions were more common in that age group. He argued that the 16- and 17-year-olds be made a “special population” that would be given specific attention and guidance for vaccination from the federal agencies and professional societies.
Dosing: 2-dose series, 3 weeks apart.
Is the COVID-19 vaccine safe? : The most commonly reported side effects in the Pfizer vaccine trials included pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Such side effect often indicate that the immune system is responding to the vaccine.
What does the FDA’s Emergency Use Authorization Mean?: When safety and quality criteria are met, EUA allows the use of unapproved medical products, or unapproved uses of approved medical products in an emergency in order to diagnose, treat, or prevent serious or life-threatening diseases.
Will the vaccine prevent COVID-19?: Based on the trials, the vaccine was effective in preventing mild and severe forms of COVID-19 across various age groups and demographics. In trials, Pfizer’s vaccine has demonstrated to be 95% effective in preventing COVID-19 infection.
Who should get the Pfizer COVID-19 Vaccine?: Individuals 16 years of age and older.
Who should not get the Pfizer vaccine?: If an individual had a severe allergic reaction after a previous dose of this vaccine, had a severe allergic reaction to any component of this vaccine.
Components: 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.
What about pregnant or breastfeeding?: Do not receive the vaccine at this time.
How long does immunity last: More research is needed.
Is the vaccine mandatory: The vaccine is not mandatory for team members, including physicians.
Vaccination after COVID-19?: It is recommended that those who have had COVID-19 also get the vaccine. It should be delayed for at least 90 days after first testing positive, as current evidence suggests that reinfection is uncommon during that time period.
What about children: A COVID-19 vaccine may not be available for children until more studies are completed.
Masking after receiving the vaccine?: People will still need to wear masks and practice socially distancing and thorough handwashing and/or sanitizing. It will take time to immunize enough of the population to stop the virus from spreading.
1213: Baricitinib compares with dexamethasone: Dexamethasone has a long half-life, acts on glucocorticoid receptors, and decreases inflammation through a broad-pathway approach, associated with immunosuppression, hospital-acquired infections, gastrointestinal bleeding, hyperglycemia, and neuromuscular weakness, even with short courses. Baricitinib has a short half-life, acts on targeted critical pathways to reduce inflammation and minimizes biologic redundancy with less immunosuppression, and may also have antiviral activity.
Dr KK Aggarwal
President CMAAO, HCFI and Past National President IMA
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