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Tag: European Medicines Agency (EMA)

EMA: Rolling evaluation of Pfizer/BioNTech’s updated coronavirus vaccine begins

EMA: Rolling evaluation of Pfizer/BioNTech’s updated coronavirus vaccine begins EMA: Rolling evaluation of Pfizer/BioNTech’s updated coronavirus vaccine begins

The European Medicines Agency (EMA) announced today that it has started the rolling evaluation of a variant-adapted Covid-19 vaccine from Pfizer and BioNTech. The bivalent (or bivalent) vaccine targets two strains of the SARS-CoV-2 virus that causes Covid-19, the original strain identified in China and Omicron’s BA.4/5 substrains, which are currently behind most cases of […]

Coreper: Expects data on Omicron variant vaccines between April and July

Coreper: Expects data on Omicron variant vaccines between April and July Coreper: Expects data on Omicron variant vaccines between April and July

The head of the European Medicines Agency (EMA) vaccine expert said on Thursday that data on COVID-19 vaccines adapted for the Omicron mutation should be available between April and early July, possibly paving the way for approval. this summer, Reuters reported. Vaccine manufacturers such as Moderna and Pfizer have begun testing COVID-19 vaccines designed for […]

BioNTech leader: We should get used to living with coronavirus for the next 10 years

BioNTech leader: We should get used to living with coronavirus for the next 10 years BioNTech leader: We should get used to living with coronavirus for the next 10 years

BioNTech vaccine against coronavirus’s Micron mutation delayed. Ugur Sahin, head of the German nanotechnology company, told Bild television that the vaccine would be ready in April or May. He argued that the delay was due to the European Medicines Agency. “Delivery of the vaccine against the Omicron variant is postponed to April or May,” said […]

Coreper has started the evaluation of the request for use of a booster dose of the BioNTech / Pfizer vaccine in adolescents 12-15 years old

Coreper has started the evaluation of the request for use of a booster dose of the BioNTech / Pfizer vaccine in adolescents 12-15 years old Coreper has started the evaluation of the request for use of a booster dose of the BioNTech / Pfizer vaccine in adolescents 12-15 years old

The European Medicines Agency (EMA) has begun evaluating an application for Comirnaty booster dose (BioNTech / Pfizer vaccine) for adolescents aged 12 to 15 years. The application is also in progress for older adolescents aged 16 to 17 years. Booster doses in vaccinated people (ie in people who have completed their initial vaccination) are given […]

Emer Cook (EMA): There is no evidence that vaccine modification is required for Omicron

Emer Cook (EMA): There is no evidence that vaccine modification is required for Omicron Emer Cook (EMA): There is no evidence that vaccine modification is required for Omicron

The European Union’s Drugs Regulatory Authority is preparing for the need to modify coronavirus vaccines to treat the new Omicron variant, but there is no evidence that this will be necessary, the head of the European Medicines Agency said on Tuesday. , Emer Cook. “There is no answer as to whether we will have to […]

Coreper: A modified vaccine for the Omicron strain could be approved in 3-4 months

Coreper: A modified vaccine for the Omicron strain could be approved in 3-4 months Emer Cook (EMA): There is no evidence that vaccine modification is required for Omicron

The EU drug regulator said on Tuesday it could approve vaccines tailored to specifically target the mutated coronavirus strain within 3-4 months if needed, but added that existing vaccines would continue to provide protection. Speaking to the European Parliament, the Executive Director of the European Medicines Agency (EMA), Emer Cook, stressed that it was not […]

The EMA has begun evaluating the conditional marketing authorization application for the Novavax vaccine

The EMA has begun evaluating the conditional marketing authorization application for the Novavax vaccine The EMA has begun evaluating the conditional marketing authorization application for the Novavax vaccine

The EMA has begun evaluating the conditional marketing authorization application for the Novavax vaccine for COVID-19, Nuvaxovid. The evaluation will proceed quickly and a marketing authorization opinion could be issued within weeks if the data submitted is strong and complete enough to show the efficacy, safety and quality of the vaccine. Such a short time […]