[ad_1]
To provide peace of mind and support for vaccination in the US, the team of allergists sought to provide clear guidance to patients in accordance with the recommendations of the US regulatory agencies.
Based on data from clinical trials for the Pfizer-BioNTech and Moderna vaccines, the authors observed an equally low rate of allergic reactions to COVID-19 vaccines. The rate of allergic reactions to the vaccine for the Pfizer-BioNTech vaccine was approximately 1.3 falls per 1 million people, while reactions occurred in less than 2% of the participants in the Moderna vaccine trial.
Prior to the FDA (USA) emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine, the UK Human Medicines Commission initiated its national COVID-19 vaccine program. Within 48 hours, there were two reports of severe allergic reactions in the UK that required epinephrine treatment.
This prompted the FDA to conduct a more detailed review of the clinical data for each vaccine. One case of anaphylaxis and one case of drug hypersensitivity reaction were reported in the Pfizer-BioNTech vaccine trial, and two cases of delayed hypersensitivity reactions were reported in the Moderna trial (one of which was probably not due to vaccination).
In Moderna’s trial, there were three lip / face swelling events one to two days after vaccination, but these occurred exclusively in patients with a history of dermal fillers. Serious hypersensitivity or anaphylactic reactions were not reported immediately after vaccination.
As in the UK, within days of the start of the US COVID-19 vaccination program, there were several reports of allergic reactions to the vaccine. At the end of December, 10 cases of allergic reactions to the Pfizer-BioNTech vaccine (out of more than 2 million doses administered) and two reports of a reaction to the Moderna vaccine were reported in the US.
Current US FDA guidance for both vaccines is not to administer the vaccine to people with a known history of severe allergic reactions to any component of the vaccine. Additionally, the US Centers for Disease Control and Prevention (CDC) advises that all patients should be observed for 15 minutes after vaccination to identify and monitor anaphylaxis.
The authors noted that allergic reactions to vaccines are not usually attributed to active ingredients, but rather to inactive ingredients (excipients) such as egg protein, gelatin, formaldehyde, thimerosal, or neomycin. These ingredients are often added to strengthen the immune response, prevent bacterial contamination, or stabilize the vaccine during transport and storage.
Other excipients such as polyethylene glycol (PEG) improve the water solubility of vaccines and have been identified as a rare cause of allergic reactions to vaccines in the past. In particular, both the Pfizer-BioNTech and Moderna vaccines are formulated with PEG to stabilize lipid nanoparticles containing messenger RNA (mRNA). There have been attempts to use safer alternatives, but negative allergic results are generally outweighed by the benefits of better drug performance.
Many allergists have hypothesized that cases of anaphylaxis during the launch of the COVID-19 vaccine could potentially be due to a pre-existing allergy to PEG. However, evidence to support this theory is lacking to date. The authors explained that measurement of serum PEG, complement, and anti-tryptase antibodies could help elucidate the specific mechanism of drug-induced reactions after COVID-19 vaccines.
The team of allergists came up with detailed advice so that people with different allergy backgrounds can safely receive COVID-19 vaccines. They proposed that patients answer screening questions about their history of severe allergic reactions. If the patient answers yes to any of the questions, then they should be monitored for a longer period of time after vaccination or should consult with an allergist to assess the risk of skin test reactions.
For patients experiencing possible reactions to the first dose of a COVID-19 vaccine, the authors suggested that healthcare workers should prioritize determining whether an allergic reaction occurred and whether the vaccine was responsible. They recommend skin tests for these patients and if the results are positive, a second dose of the vaccine should be avoided.
“As allergists, we want to encourage vaccination by assuring the public that the two FDA-approved COVID-19 vaccines are safe,” said Dr. Aleena Banerji, clinical director of the Allergy and Clinical Immunology Unit at Massachusetts General Hospital and professor. Harvard associate. Faculty of Medicine, in a statement. “Our guidelines are based on recommendations from US regulatory agencies and provide clear steps to the medical community on how to safely administer both doses of the vaccine to people with a history of allergies.”
Do you have a unique perspective on your research related to immunology or vaccine development? Contact the publisher today for more information.
—
Copyright © 2021 scienceboard.net
