AstraZeneca struggles with data needed for COVID-19 vaccine’s approval

29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout ...

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FDA and CDC lift recommended pause on Johnson & Johnson (Janssen) COVID-19 vaccine use following thorough safety review

23 April 2021 - Agencies underscore confidence in vaccine’s safety and effectiveness following data assessment; available data suggest potential blood clots ...

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FDA continues important steps to ensure quality, safety and effectiveness of authorised COVID-19 vaccines

21 April 2021 - The U.S. FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously.  ...

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Fauci says he expects a decision Friday on whether the U.S. can resume using Johnson & Johnson’s vaccine

18 April 2021 - A decision about whether to resume administering the Johnson & Johnson COVID-19 vaccine should come this ...

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U.S. FDA to scrutinise vaccine design behind COVID-19 shots linked to blood clots

13 April 2021 - With two COVID-19 vaccines now under scrutiny for possible links to very rare cases of blood ...

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Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine

13 April 2021 - The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation ...

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Pfizer requests FDA clearance for vaccine in kids ages 12 to 15

9 April 2021 - The FDA's review process will probably take several weeks, experts say. The move would make Pfizer's vaccine ...

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FDA makes two revisions to Moderna COVID-19 vaccine emergency use authorization to help increase the number of vaccine doses available

1 April 2021 - Today, the U.S. FDA announced two revisions regarding the number of doses per vial available for the ...

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AstraZeneca vaccine trial data questions raised by US drug agency

23 March 2021 - Promising results announced on Monday from AstraZeneca’s American vaccine trials may have relied on an incomplete ...

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U.S. plans to use real world and trial data to determine when vaccines need to be updated

17 March 2021 - U.S. officials plan to use data gathered from people who have already been vaccinated against COVID-19 as ...

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Facebook to label all posts about coronavirus vaccines

15 March 2021 - Facebook, which has been criticised by politicians and researchers for allowing vaccine misinformation to spread on ...

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Seqirus announces U.S. FDA approval of expanded age indication of its cell based quadrivalent influenza vaccine for people two years of age and older

5 March 2021 - Seqirus today announced that the U.S. FDA has approved Flucelvax Quadrivalent (influenza vaccine), the company's cell-based quadrivalent ...

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Women report worse side effects after a COVID-19 vaccine

8 March 2021 - Men and women tend to respond differently to many kinds of vaccines. That’s probably because of a ...

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FDA allows more flexible storage, transportation conditions for Pfizer-BioNTech COVID-19 vaccine

25 February 2021 - Update Provides Alternative Temperature for Transportation and Temporary Storage for Frozen Vials Before Dilution. ...

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Johnson & Johnson COVID-19 vaccine authorised by U.S. FDA for emergency use - first single shot vaccine in fight against global pandemic

27 February 2021 - Johnson & Johnson today announced that the U.S. FDA has issued emergency use authorisation for its single-dose ...

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