The European Union’s drug regulator on Friday said it is recommending adding “heavy menstrual bleeding” as a side effect to both Pfizer’s and Moderna’s COVID-19 vaccines, according to an advisory panel meeting. The European Medicines Agency’s (EMA) safety committee said that “heavy menstrual bleeding should be added to the product information as a side effect…
ET Drug Regulator Recommends Adding ‘Heavy Menstrual Bleeding’ as mRNA COVID-19 Vaccine Side-Effect
EU Drug Regulator Recommends Adding ‘Heavy Menstrual Bleeding’ as mRNA COVID-19 Vaccine Side-Effect
The European Union’s drug regulator on Friday said it is recommending adding “heavy menstrual bleeding” as a side effect to both Pfizer’s and Moderna’s COVID-19 vaccines, according to an advisory panel meeting. The European Medicines Agency’s (EMA) safety committee said that “heavy menstrual bleeding should be added to the product information as a side effect…
EU Approves Pfizer’s COVID-19 Pill for Adults at Risk of Severe Disease
The European Commission (EC) on Friday authorized the use of Pfizer’s COVID-19 antiviral pill one day after the European Unions’ (EU) drugs regulator backed the treatment for adults who do not require supplemental oxygen and who are at increased risk of severe disease. Stella Kyriakides, the EU’s commissioner for health and food safety, called it “a key…
EU Regulator Backs Giving J&J Booster Shot to Adults 2 Months After Initial Dose
The European Union’s drug regulator on Wednesday concluded a Johnson & Johnson (J&J) COVID-19 booster dose may be considered for people aged 18 and older at least two months after their initial shot. In a Dec. 15 statement, the European Medicines Agency (EMA) said the recommendation by the agency’s human medicines committee follows data it…
EU Regulator Backs Giving COVID-19 Shots to Children Aged 5 to 11
The European Union’s drug regulator on Thursday recommended expanding the use of Pfizer-BioNTech’s COVID-19 vaccine for children from 5 to 11 years old. The decision, announced by the European Medicines Agency (EMA), cited Pfizer’s clinical trial data, which the company says indicates a 90.7 percent efficacy in preventing illness in the age group. “The benefits…
EU Regulator Backs Pfizer Booster Shots for People 18 and Older
The European Union’s drug regulator on Monday gave the approval to administer booster shots of the Pfizer-BioNTech COVID-19 vaccine dubbed Comirnaty to people aged 18 and older. “The [Committee for Medicinal Products for Human Use] has evaluated data for Comirnaty showing a rise in antibody levels when a booster dose is given approximately 6 months…
EU Regulator Unable to Confirm If Women Face Increased Clot Risks After AstraZeneca Shot
Europe’s drug regulator said on Friday that it could not confirm whether AstraZeneca’s COVID-19 vaccine has any influence on higher risks for unusual blood clots associated with low levels of blood platelets in women and younger adults. The European Medicine Agency (EMA) said in a statement it was requested by the European Commission to provide…
EMA Official Says AstraZeneca Shots Have Good Risk-Benefit Profile for Over 60s
MILAN—The head of the EU drug regulator’s COVID-19 task force said on Sunday that AstraZeneca’s coronavirus vaccine had a favorable risk-benefit profile for all age groups and particularly for those aged over 60. Italian newspaper La Stampa earlier quoted European Medicines Agency (EMA) task force chief Marco Cavaleri as saying countries should avoid giving the…
Norway Should Exclude J&J, AstraZeneca From Vaccine Scheme: Panel
OSLO—Norway should exclude the COVID-19 vaccines made by AstraZeneca and Johnson & Johnson from its inoculation program due to a risk of rare but harmful side-effects, a government-appointed commission said on Monday. However, those who volunteer to take either vaccine should be allowed to do so, it said, stressing the importance of dispelling any vaccine…
Pfizer, BioNTech Seek EU’s OK to Use COVID-19 Vaccine on Kids
LONDON—Pfizer Inc. and BioNTech have submitted a request to the European drug regulator for the approval of their coronavirus vaccine to be extended to include children 12 to 15 years old, in a move that could offer younger and less at-risk populations in Europe access to the shot for the first time. In a statement…
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