The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the United States (non-listed food allergens).
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Three new conditions reported by a small number of people after vaccination with Covid-19 shots from Pfizer and Moderna are being studied to assess if they may be possible side effects, Europe’s drugs regulator said on Aug. 11.
The U.S. Centers for Disease Control and Prevention is observing a lower rate of severe allergic reactions in people in the United States who have received Pfizer Inc. and BioNTech SE’s Covid-19 vaccine.
Severe allergic reactions to Moderna Inc.’s coronavirus vaccine appear to be quite rare, the U.S. Centers for Disease Control and Prevention (CDC) said, after more than 4 million people received their first dose.
Moderna Inc. received a report from California’s health department that several people at a center in San Diego were treated for possible allergic reactions to the company’s Covid-19 vaccine from a particular batch.
Top U.S. Food and Drug Administration regulators said most Americans with allergies should be safe to receive the Covid-19 vaccine developed by Pfizer Inc. and Germany’s Biotech SE.
FDA Advisory Committee Gives Green Light to Pfizer-BioNTech Covid-19 Vaccine"Operation Warp Speed" Initiative, Advisory Committees, Airlines, Allergic Reactions, BioNTech, Clinical Trials, COVID-19 Vaccines, Efficacy Data, Emergency Use Authorization, FDA, Federal Aviation Administration (FAA), Messenger RNA (mRNA) Vaccines, Pfizer, R&D, The Wall Street Journal, United Kingdom
The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted 17-4 to recommend Pfizer and BioNTech’s Covid-19 vaccine for Emergency Use Authorization (EUA) for individuals ages 16 years and older.
UK regulators stated that they received two reports of potential allergic reactions linked to the Covid-19 vaccine from Pfizer and BioNTech, according to the Associated Press.
Sociétés des Produits Nestlé, a part of Nestlé Health Science, acquired the outstanding shares of California-based Aimmune for $2.6 billion in cash following years of increasing its financial position in the food allergy-focused company.
EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a study that concludes patients might need expensive refills less often.