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Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show

pharmaphorum

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. As it conducted its analysis of the vaccine in December, the European Medicines Agency’s systems were targeted by unknown hackers.

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Top Russian doctor quits over questionable ethics that rushed through coronavirus vaccine

The Pharma Data

Professor Alexander Chuchalin has quit the Russian Health Ministry’s ethics council due to the quick approval process for the country’s coronavirus vaccine. Many countries have criticised Russia pursuit for a COVID-19 cure, which has skipped Phase 3 trials before giving the vaccine regulatory approval. Safety always comes first.

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US experts stress over safety of AZ’s COVID-19 vaccine

pharmaphorum

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. The post US experts stress over safety of AZ’s COVID-19 vaccine appeared first on.

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No COVID-19 Vaccines Allowed in California Without State Approval

The Pharma Data

No COVID-19 Vaccines Allowed in California Without State Approval. 20, 2020 — California is not going to allow the use of any COVID-19 vaccines until its own panel of experts approves them, Gov. The governor named 11 doctors and scientists who will review any vaccines approved by the federal government or vaccine developers.

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FDA Will Follow The Science On COVID-19 Vaccines For Young Children

The Pharma Data

Many parents have questions on COVID-19 and when vaccines are going to be available for youngsters younger than 12 years aged. We are therefore also wanting to see COVID-19 vaccines available for young children. Some have stated that they’re still enrolling, and a few are still administering doses or following participants.

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New Trivalent Flu Vaccine for 2024/2025 and Other Insights from Leading Infectious Disease Experts Dr. Willliam Schaffner and Dr. Kelly Moore

XTalks

Influenza viruses are highly mutable, which necessitates continuous monitoring and adjustments in vaccine formulations. These seasonal outbreaks can vary in severity, depending on the circulating strains of the virus and public health preparedness, including vaccination coverage and effectiveness.

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Keeping tabs on Covid-19: Updates on the second Covid-19 vaccine approved in the UK and Bayer’s latest global supply chain infrastructure deal

The Pharma Data

For example, pharmaceutical regulatory bodies are working tirelessly to fast track the approval of vaccines to treat Covid-19, doctors are now better prepared to handle patients with coronavirus and testing is becoming faster and more accessible. The New Year brings new hope as UK regulators approve Oxford vaccine for emergency use.