Comirnaty

EU authorises first COVID-19 vaccine for 5 to 11 year olds

The European Medicines Agency (EMA) has approved Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children between the ages of five and 11, as EU countries struggle to cope with rising infection rates. The EU regulator said that the under-12s should get a lower dose of the vaccine – 10 mcg rather than 30 mcg – …

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FDA delays review of Moderna COVD jab in adolescents

The FDA has said it needs more time to review Moderna’s application for emergency use of its COVID-19 vaccine mRNA-1273 in children aged 12 to 17, as it looks at data on heart inflammation in people receiving the shot. The decision leaves Moderna playing catch-up with Pfizer and BioNTech, whose Comirnaty vaccine was approved for …

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CDC director backs COVID-19 jab for 5 to 11s, plus a fourth shot

The US looks set to see a big expansion of the country’s COVID-19 vaccination drive, with shots looking likely for children aged five to 11 as well as a fourth dose for adults who are immunocompromised. FDA advisors gave a green light to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children in that younger age …

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FDA advisors mull use of Pfizer/BioNTech COVID-19 jab in kids

FDA advisors will meet later today discuss the possibility of authorising Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in children as young as five years old. If the Vaccines and Related Biological Products Advisory Committee (VRBPAC) gives the go-ahead, the FDA could approve emergency-use of Comirnaty in five to 11-year-olds in a matter of days, extending …

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EU backs broader use of Comirnaty as COVID booster than US

The EMA has given the go-ahead to the use of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty as a booster for all people aged 18 or more, but says EU member states must decide for themselves whether to make a third dose available to their citizens. The regulator’s human medicines committee (CHMP) said that a third …

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FDA approves Pfizer COVID booster jabs for higher-risk groups

Just days after its advisory committee meeting voted to approve a third dose of Pfizer and BioNTech’s COVID-19 vaccine, the FDA has followed through and cleared the shot. The FDA has amended the emergency use authorisation (EUA) for Comirnaty in line with its experts’ advice – for people aged over 65 and other adults at …

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Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this …

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Pfizer, BioNTech prep low-dose COVID jab filing for kids aged 5 to 11

With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to move swiftly ahead with a filing for emergency use that could be approved in a matter of weeks. The data is the first generated with any COVID-19 vaccine in this …

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EMA looks at booster data for Pfizer/BioNTech COVID-19 jab

The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine given six months after the first course to people aged 16 and over. The EMA’s CHMP human medicines committee will carry out an accelerated review of the application, which comes …

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Pfizer and BioNTech’s Comirnaty Receive the US FDA’s Approval to Prevent COVID-19 in Individuals Aged 16 Years and Older

Shots: The approval is based on the longer-term follow-up data from the P-III trial that showed high efficacy and favorable safety profile through 6mos. after the second dose The vaccine will now be marketed as Comirnaty and is fully approved for the prevention of COVID-19 in individuals aged ≥16 yrs. The companies also plan to …

Pfizer and BioNTech’s Comirnaty Receive the US FDA’s Approval to Prevent COVID-19 in Individuals Aged 16 Years and Older Read More »

FDA grants full approval to Pfizer/BioNTech COVID jab

Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US. The regulator has cleared the vaccine – now officially given the trade name Comirnaty – to prevent COVID-19 in people aged 16 or more, …

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Pfizer and BioNTech Receive EC’s Conditional Marketing Approval for the COVID-19 Vaccine in Adolescents

Shots: The approval is based on a P-III study assessing Comirnaty (two 30μg doses) in 2,260 participants aged 12-15yrs. and showed 100% efficacy in participants with/out prior SARS-CoV-2 infection, robust Ab responses and was well tolerated The approval follows CHMP’s positive opinion to authorize the vaccine in this group. The extended indication for the CMA …

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Pfizer and BioNTech’s Comirnaty (BNT162b2) Receives EC’s Conditional Marketing Authorization for COVID-19

Shots: The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio of (1:1) for COVID-19. The approval follows CHMP’s positive opinion to authorize the vaccine The P-III demonstrated 95% ER in participants without prior SARS-CoV-2 infection (first primary objective) and in …

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