I am hoping the trend on the graph continues.
Fall Newsletter 2021
Third Dose or Booster of Covid 19 Vaccine
Quarantine and Isolation: Updated Guidelines
What to do if You Test Positive for Covid 19
We are still in the midst of a surge of Covid 19 cases and preparing to vaccinate our patients against Influenza, another preventable respiratory disease. Last year, we had more people get vaccinated for influenza than ever before. We also experienced the fewest cases of influenza that I recall. In fact, I didn’t treat a single case of the flu. We are scheduled to receive our first shipment of vaccine at the beginning of September. We never know whether they will give it all at once or in multiple shipments.
We will schedule vaccine appointments. If we run out, we will take names and call people when we receive our next shipment and set them up to come in. Flu vaccine is plentiful and there is no need to get it tomorrow.
Many people have questions regarding Covid 19 boosters and that will be covered, but there is recent information that the flu vaccine and Covid 19 vaccines may be administered at the same time.
Co-administration of Influenza Vaccines with COVID-19 Vaccines ▪ From the “Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States” – “COVID-19 vaccines were previously recommended to be administered alone, with a minimum interval of 14 days before or after administration of any other vaccines. This was out of an abundance of caution and not due to any known safety or immunogenicity concerns. However, substantial data have now been collected regarding the safety of COVID-19 vaccine currently authorized by FDA for use under EUA…COVID-19 vaccines and other vaccines may now be administered without regard to timing.” – “Administer the COVID-19 vaccines and vaccines that may be more likely to cause a local reaction (e.g., tetanus-toxoid-containing and adjuvanted vaccines) in different limbs, if possible.” https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.htm
Plans to provide booster doses for the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines were announced by representatives of the CDC, FDA, NIH, and other government entities on Aug. 18. The joint statement said that the officials have concluded that a booster shot “will be needed to maximize vaccine-induced protection and prolong its durability” and “are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose.” On Aug. 23, the FDA gave its approval to the Pfizer-BioNTech COVID-19 vaccine, which the FDA’s press release noted will now be marketed as Comirnaty, for the prevention of COVID-19 disease in patients 16 years of age and older. The emergency use authorization of the vaccine continues to apply to its administration to children 12 through 15 years of age and as a third dose to immunocompromised patients.
Many people have rushed to get a booster, but the recommendation is that a third dose be given now only to immunocompromised individuals such as patients who have had transplants or are immunosuppressed by nature of an illness or the medication that they take to treat it. The distinction is that those individuals may not have responded to the first two doses so a third dose is required. A booster is given as immunity wanes over time. Testing for antibodies is not recommended prior to third doses or boosters. Pharmacies have not been asking for any proof that one is immunocompromised.
Healthcare workers and nursing home residents are to qualify for booster doses beginning in September. For all others, the recommendation is to get the booster 8 months after the second dose. We don’t have any evidence that taking it earlier is better. As I write this, there is now a recommendation that boosters be given 6 months after the second dose. Please remember that the FDA, CDC and ACIP have to agree on these recommendations. I post updates regularly on my blog, http://www.personalphysicianmd.com/covid-19/
No recommendation has been made yet for those people who took the J and J vaccine.
We are not able to offer two Covid 19 vaccines while trying to give the flu vaccine as well. In contrast to the rollout of the Covid 19 vaccines, it is easy to schedule an appointment to get it at your pharmacy. There is also a tool to locate vaccines, Vaccines.gov – Find COVID-19 vaccine locations near you or you can go to your local pharmacy’s website.
QUARANTINE AND ISOLATION GUIDE FOR VACCINATED AND UNVACCINATED INDIVIDUALS
Here is a handy guide from the CDC on isolation and quarantine.
IF YOU TEST POSITIVE FOR COVID 19:
You would contact us. We would then decide based on your symptoms and risk factors for progression to severe Covid 19 whether to send you for an antibody infusion. Regen Cov is a combination of monoclonal antibodies against Covid 19 that is administered through an infusion. It takes about two hours and is administered at several centers around town. It may accelerate the recovery, but more importantly, it may help you avoid hospitalization. Only 30% of people who qualify for monoclonal antibodies receive them. Also, Regen Cov can now be administered to people who have been exposed BEFORE they get sick if they are at high risk of developing severe Covid 19. From THE MEDICAL LETTER:
August 23, 2021
Casirivimab and Imdevimab (REGEN-COV) for Post-Exposure Prophylaxis of COVID-19
Download PDF: US English
August 23, 2021 (Issue: 1631)
The investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV – Regeneron) have been available in the US under an Emergency Use Authorization (EUA) since late 2020 for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization.1 The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons, if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response to full vaccination and have been in close contact with a SARS-CoV-2-infected individual or are likely to be exposed to SARS-CoV-2 in the setting of an institutional outbreak (see Table 1).2 Casirivimab and imdevimab are the first drugs to receive an EUA for post-exposure prophylaxis of COVID-19.
ELIGIBILITY — In May 2021, the FDA expanded the criteria by which a patient with COVID-19 can be considered at high risk for disease progression. All persons ≥12 years old who are overweight or pregnant or have cardiovascular disease, hypertension, or chronic respiratory disease are now considered high-risk (see Table 2).3
CLINICAL STUDIES — Expansion of the EUA was based on the results of a randomized, double-blind, placebo-controlled trial in 1505 healthy, unvaccinated patients ≥12 years old without evidence of prior immunity who were household contacts of persons with SARS-CoV-2 infection (positive test within the prior 96 hours). Patients received a single subcutaneous dose of casirivimab and imdevimab (600 mg each) or placebo.
Symptomatic SARS-CoV-2 infection within 4 weeks of randomization, the primary endpoint, occurred significantly less often in patients who received the antibodies than in those who received placebo (1.5% vs 7.8%; adjusted OR 0.17 [95% CI 0.09-0.33]; NNT 15.4). Among patients who developed symptomatic infection, the duration of symptoms was significantly shorter in the antibody group (mean 1.2 vs 3.2 weeks with placebo). There were no hospitalizations or emergency department visits due to COVID-19 in the antibody group, compared to 4 in the placebo group.4
VARIANTS — To date, casirivimab plus imdevimab has retained activity against all strains of SARS-CoV-2 designated by the WHO as Variants of Concern, including the Delta (B.1.617.2) variant.2
ADVERSE EFFECTS — Infusion- and injection-related reactions and anaphylaxis have been reported with use of casirivimab and imdevimab.
DOSAGE AND ADMINISTRATION — The authorized dosage of REGEN-COV for post-exposure prophylaxis is 600 mg of casirivimab and 600 mg of imdevimab given as either 4 consecutive SC injections at one time or a single IV infusion. There is no preference for IV over SC administration of REGEN-COV when it is used for post-exposure prophylaxis. In patients with ongoing exposure to SARS-CoV-2, additional 300-mg doses of casirivimab and imdevimab can be administered every 4 weeks. Detailed instructions on preparation and administration of the antibodies are available in the FDA Fact Sheet.2
CONCLUSION — The FDA has authorized the monoclonal antibodies casirivimab and imdevimab (REGEN-COV) to be administered together for post-exposure prophylaxis of COVID-19 in certain high-risk individuals. In a double-blind trial in household contacts of SARS-CoV-2-infected persons, subcutaneous administration of REGEN-COV reduced the risk of symptomatic infection significantly more than placebo. Casirivimab plus imdevimab has retained activity against all SARS-CoV-2 Variants of Concern to date.
- An EUA for casirivimab and imdevimab for COVID-19. Med Lett Drugs Ther 2020; 62:201.
- FDA. Fact sheet for health care providers. Emergency Use Authorization (EUA) of REGEN-COV™ (casirivimab and imdevimab). July 2021. Available at: https://bit.ly/3A4N0i7. Accessed August 5, 2021.
- FDA News Release. Coronavirus (COVID-19) update: May 21, 2021. Available at: https://bit.ly/3fFoEUB. Accessed August 5, 2021.
- MP O’Brien et al. Subcutaneous REGEN-COV antibody combination to prevent Covid-19. N Engl J Med 2021 August 4 (epub).
© The Medical Letter, Inc. All Rights Reserved.
Due to the high levels of virus in the community, it is recommended to wear a mask indoors when in public places. We have been masking in the office since March 14, 2020 and asking our patients to as well. People ask us why we continue to require masks when seeing vaccinated patients. The answer is that vaccinated individuals may still have asymptomatic infections which are contagious. Asymptomatic infections are more common with the delta variant than the previous alpha variant, so we continue to wear masks in the office. We want to keep patients and staff safe.
It’s going to be an interesting fall. We will do our best to continue to advise you on how to keep safe.
Wishing you the best of health.
Mark L. Thornton, M.D.,F.A.C.P.