BioNTech plans to make vaccines in shipping containers

19 February 2022 - These standardised factories could be quickly scaled up to expand capacity worldwide. ...

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European Medicines Agency approves Pfizer’s 20 valent pneumococcal conjugate vaccine against invasive pneumococcal disease and pneumonia in adults

15 February 2022 - Apexxnar [pneumococcal polysaccharide conjugate vaccine (20 valent, adsorbed)] is the first pneumococcal conjugate vaccine to help protect ...

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Novavax underdelivers on COVID vaccine promises

9 February 2022 - Novavax has delivered just a small fraction of the 2 billion COVID-19 shots it plans to ...

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EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents

8 February 2022 - EMA has started evaluating an application for the use of a booster dose of Comirnaty (BioNTech/Pfizer’s vaccine) ...

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EU watchdog says supports fast development of Omicron only vaccine

3 February 2022 - The European Union's drug regulator said on Thursday it would support a filing for approval of ...

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International regulators’ recommendations on COVID-19 vaccines and the Omicron variant

21 January 2022 - International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against ...

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COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy

18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...

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Global regulators discuss path towards regulatory alignment on response to Omicron variant

13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...

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Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant

11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...

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Pfizer and BioNTech submit updated longer-term follow-up data of Comirnaty in adolescents 12 through 15 years of age to EMA

23 December 2021 - Pfizer and BioNTech today announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase ...

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EMA recommends Nuvaxovid for authorisation in the EU

20 December 2021 - EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as ...

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CHMP issues positive opinion for Pfizer’s 20 valent pneumococcal conjugate vaccine for the prevention of vaccine type pneumococcal pneumonia in adults

17 December 2021 - Pfizer announced today that the CHMP of the EMA has issued a positive opinion to recommend the ...

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COVID-19 Vaccine Janssen: EMA recommendation on booster dose

15 December 2021 - EMA’s CHMP has concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at ...

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International regulators stress continued need for COVID-19 therapeutics

11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...

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Novavax COVID-19 vaccine could be approved very soon, says EMA chief

8 December 2021 - The head of the EMA on Tuesday said that it could soon approve the COVID-19 vaccine ...

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