FDA, CDC approve second covid-19 booster dose for certain populations
FDA, CDC approve second COVID-19 booster for Americans 50 and older
On Tuesday, March 29th the FDA approved a second COVID-19 booster dose for those 50 years and older and for certain immunocompromised individuals.
Talk to your healthcare provider about COVID-19 vaccination and your medical condition.
Guidelines on COVID-19 vaccines are updated regularly. You can read the latest recommendation here:
CDC: https://www.cdc.gov/media/releases/2022/s0328-covid-19-boosters.html
FDA: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and
On Tuesday, March 29th the FDA approved a second COVID-19 booster dose for those 50 years and older and for certain immunocompromised individuals.
- CDC has updated its recommendations to allow certain immunocompromised individuals and people over the age of 50 who received an initial booster dose at least 4 months ago to be eligible for another mRNA booster to increase their protection against severe disease from COVID-19.
- Separately, they recommend that adults who received a primary vaccine and booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least 4 months ago may now receive a second booster dose using an mRNA COVID-19 vaccine.
Talk to your healthcare provider about COVID-19 vaccination and your medical condition.
Guidelines on COVID-19 vaccines are updated regularly. You can read the latest recommendation here:
CDC: https://www.cdc.gov/media/releases/2022/s0328-covid-19-boosters.html
FDA: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and
update on covid-19 guideline for adults
We are now farther along in the pandemic and on to the third major variant, omicron, which is now dominant. This variant presents a totally different disease pattern than the others.
Here are updated management recommendations.
If a person requires hospitalization for Covid-19, Sotrovimab plus dexamethasone are commonly used.
Here are updated management recommendations.
- We encourage patients to take advantage of the available vaccines and completes the course
- two doses of Pfizer plus a booster, or
- two doses of Moderna plus a booster, or
- one dose of J&J plus an mRNA booster.
- If a breakthrough case of the omicron variant occurs, the symptoms will usually be minor if the individual has had the full set of vaccines. Most people have a sore throat and stuffy nose and can stay home (even if they have adrenal insufficiency) if they have no symptoms of pneumonia or high fever.
- However, if acute Covid-19 occurs in an unvaccinated or partially vaccinated person, the disease may be more severe. If significant symptoms do occur, we now have two potential treatments that can provide improvement and potentially reduce the need for hospital treatment. They are Sotrovimab, a monoclonal antibody infusion that works for omicron and Paxlovid, an oral medication from Pfizer.
- Each of these treatments must be started within 5 days of the onset of symptoms, but preferable within 3 days.
- The personal physician treating the patient must have proof of a positive PCR and refer the patient to a regional hospital or health system that has access to these drugs. The final determination and prescription will be made by that facility based on availability, severity of disease, and guidelines that are used to stratify the risk of severe complications with the person's medical history.
- Those with a severe illness of any kind that necessitates Emergency Department treatment will require stress doses of glucocorticoids using our usual guidelines.
- Steroid dosing guidelines for illness are found here https://www.nadf.us/uploads/1/3/0/1/130191972/nadf_stress-dosing_guidelines.pdf
If a person requires hospitalization for Covid-19, Sotrovimab plus dexamethasone are commonly used.
FDA APPROVES ANTIVIRAL PILLS TO TREAT COVID-19 AT HOME
The Food and Drug Administration announced an emergency use authorization (EUA) of antiviral treatments for mild-to-moderate coronavirus disease (Covid-19) on December 22 and 23rd. This wonderful news provides a useful new course of action for covid-19 infections, including breakthrough cases of omicron as well as the other variants.
These antiviral treatments will eventually be for everyone, but initially will be indicated especially for those who are at high risk of complications, including those with adrenal insufficiency. The remedies will be very similar to the use of Tamiflu which is used for acute cases of influenza.
A provider will need to verify a positive PCR, symptoms of covid, and then start the treatments within 5 days of onset. However, currently these therapies are not available but are expected to be distributed gradually in the next month, with supplies increasing over the next few months.
In the meantime, those who do have breakthrough symptomatic illness should try to get the one monoclonal antibody infusion that works for omicron, though it is difficult to get because of shortages. Regeneron and Eli Lilly both announced their antibody treatments didn’t work as effectively in diffusing omicron.
Before any treatments, patients must review their current condition with their physician, including the list of medications they are currently taking. Some drugs cannot be taken with these new antiviral treatments.
More information can be found in FDA’s announcements:
Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 | FDA
Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults | FDA
These antiviral treatments will eventually be for everyone, but initially will be indicated especially for those who are at high risk of complications, including those with adrenal insufficiency. The remedies will be very similar to the use of Tamiflu which is used for acute cases of influenza.
A provider will need to verify a positive PCR, symptoms of covid, and then start the treatments within 5 days of onset. However, currently these therapies are not available but are expected to be distributed gradually in the next month, with supplies increasing over the next few months.
In the meantime, those who do have breakthrough symptomatic illness should try to get the one monoclonal antibody infusion that works for omicron, though it is difficult to get because of shortages. Regeneron and Eli Lilly both announced their antibody treatments didn’t work as effectively in diffusing omicron.
Before any treatments, patients must review their current condition with their physician, including the list of medications they are currently taking. Some drugs cannot be taken with these new antiviral treatments.
More information can be found in FDA’s announcements:
Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 | FDA
Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults | FDA
COVID-19 FOR EMERGENCY AND HOSPITAL PERSONNEL FOR CHILDREN WITH ADRENAL INSUFFICIENCY
Please refer here for information regarding ER treatment for children. The adult section is currently being updated.
https://www.nadf.us/covid19-er-hospital-children.html
https://www.nadf.us/covid19-er-hospital-children.html
UPDATE ON THE COVID-19 BOOSTER SHOTS FOR THE NADF COMMUNITY
Those who received Pfizer and had 2 shots should now get a booster 6 months after the last shot if they are 65 years of age and older or have adrenal insufficiency. The CDC has updated their guidance on booster shots to include those with underlying conditions, including individuals on glucocorticoids. This additional information is important for our community.
To see Dr. Margulies' guidance on the booster shot, visit https://www.nadf.us/covid-19-vaccine-education.html
To see Dr. Margulies' guidance on the booster shot, visit https://www.nadf.us/covid-19-vaccine-education.html
severe covid-19 risks greatly increased for children with adrenal insufficiency
March 21, 2021
Adrenal insufficiency increases the risk for severe outcomes, including death, 23-fold for children who contract COVID-19, according to a data analysis presented at the ENDO annual meeting.
Read the full article: https://www.healio.com/news/endocrinology/20210321/severe-covid19-risks-greatly-increased-for-children-with-adrenal-insufficiency
Adrenal insufficiency increases the risk for severe outcomes, including death, 23-fold for children who contract COVID-19, according to a data analysis presented at the ENDO annual meeting.
Read the full article: https://www.healio.com/news/endocrinology/20210321/severe-covid19-risks-greatly-increased-for-children-with-adrenal-insufficiency
STATEMENT FROM NADF'S MEDICAL DIRECTOR ABOUT THE johnson & johnson covid-19 vaccine
March 5, 2021
Everyone with adrenal insufficiency should get vaccinated with whichever of these vaccines is available to them. I am not concerned about the reported lower efficacy of the J&J vaccine in reducing the incidence of mild to moderate disease. The real benefit of the J&J vaccine is the astounding 100% prevention of severe disease leading to death. Also, the fact that it is one injection that does not require freezing will make it a lot easier for people in rural areas to be vaccinated. People with adrenal insufficiency in NY State are now eligible. Hopefully, this will be extended to all other states soon.
Everyone with adrenal insufficiency should get vaccinated with whichever of these vaccines is available to them. I am not concerned about the reported lower efficacy of the J&J vaccine in reducing the incidence of mild to moderate disease. The real benefit of the J&J vaccine is the astounding 100% prevention of severe disease leading to death. Also, the fact that it is one injection that does not require freezing will make it a lot easier for people in rural areas to be vaccinated. People with adrenal insufficiency in NY State are now eligible. Hopefully, this will be extended to all other states soon.
from the Centers for disease controL AND PREVENTION (cdc)
VACCINATION CONSIDERATIONS FOR PERSONS WITH UNDERLYING MEDICAL CONDITIONS
Updated December 29, 2020
Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19. mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine. The following information aims to help people in the groups listed below make an informed decision about receiving the mRNA COVID-19 vaccine.
Read the full article: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/underlying-conditions.html
Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19. mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine. The following information aims to help people in the groups listed below make an informed decision about receiving the mRNA COVID-19 vaccine.
Read the full article: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/underlying-conditions.html
STATEMENT FROM NADF'S MEDICAL DIRECTOR ABOUT THE COVID-19 VACCINE
December 17, 2020
Many are questioning whether the COVID-19 vaccine is safe for those with adrenal insufficiency. After a review, NADF’s Medical Advisor Dr. Margulies provided this statement:
“At this time, I am satisfied that the FDA has done the appropriate review of the Pfizer vaccine, and I am enthusiastic about recommending it to every adult. I plan to take it myself. There is no reason for anyone with adrenal insufficiency, whether primary or secondary, to avoid this vaccine. It is as safe as the influenza vaccine. It has mild side effects, such as sore arm, mild fever and fatigue that last about one day. The Moderna vaccine will be reviewed soon, but so far it looks very similar to the Pfizer product. Unless something surprising is found, I expect it will also be suitable for every adult.”
Additional information:
Many people in the clinical trials had some short-term side effects from taking the COVID-19 vaccine. The side effects are usually not serious -- one of the most common is a sore or achy arm. Some people develop low-grade fevers or chills and feel tired. This is because the vaccine is working and causing a response from the immune system. As always, follow NADF’s stress dosing guidelines to determine if you need additional steroids.
As always, you and your doctor should decide together if the vaccine is right for you and, if so, which one.
Many are questioning whether the COVID-19 vaccine is safe for those with adrenal insufficiency. After a review, NADF’s Medical Advisor Dr. Margulies provided this statement:
“At this time, I am satisfied that the FDA has done the appropriate review of the Pfizer vaccine, and I am enthusiastic about recommending it to every adult. I plan to take it myself. There is no reason for anyone with adrenal insufficiency, whether primary or secondary, to avoid this vaccine. It is as safe as the influenza vaccine. It has mild side effects, such as sore arm, mild fever and fatigue that last about one day. The Moderna vaccine will be reviewed soon, but so far it looks very similar to the Pfizer product. Unless something surprising is found, I expect it will also be suitable for every adult.”
Additional information:
Many people in the clinical trials had some short-term side effects from taking the COVID-19 vaccine. The side effects are usually not serious -- one of the most common is a sore or achy arm. Some people develop low-grade fevers or chills and feel tired. This is because the vaccine is working and causing a response from the immune system. As always, follow NADF’s stress dosing guidelines to determine if you need additional steroids.
- Remember that the Pfizer vaccine is given in two doses three weeks apart. It is more common to have side effects from the second dose than the first. You must receive both doses to get the full benefit from the vaccine.
- The vaccine may not be available to most people until spring or summer of 2021. Because of the limited supply of the vaccines, people at very high risk, such as health care providers and people who live in nursing homes or assisted living facilities, will get a vaccine before people whose risk of illness is lower.
As always, you and your doctor should decide together if the vaccine is right for you and, if so, which one.
