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Merck and Orna partner for RNA technology-based vaccines and therapies

Pharmaceutical Technology

Merck (MSD outside North America) has entered a partnership agreement with Orna Therapeutics for discovering, developing and marketing various programmes based on next-generation RNA technology. These programmes will include therapies and vaccines in infectious disease and oncology areas.

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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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UK prepares for decision on AZ/Oxford vaccine as COVID cases soar

pharmaphorum

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days. Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

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Moderna seeks FDA EUA for Covid-19 booster vaccine

Pharmaceutical Technology

Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 5 Omicron-targeting bivalent booster vaccine for Covid-19. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above.

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Safety Evaluation of the Second Dose of mRNA COVID-19 Vaccines in Patients With Immediate Reactions to the First Dose

JAMA Internal Medicine

This case series study examines the safety of second doses of messenger RNA COVID-19 vaccines after first-dose allergic reactions.

Vaccine 111
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H2 2022 to see the decline of Covid-19 vaccines as forecasts decrease

Pharmaceutical Technology

According to GlobalData’s Drugs database, there were 22 prophylactic vaccines in development for COVID-19 with sales forecasts available in H2 2022. Of these 22 vaccines, mRNA-derived vaccines dominate, with Comirnaty and Moderna’s Spikvax accounting for 88% of 2022 sales, with 58% and 30%, respectively.

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COVID-19 Messenger RNA Vaccination and Myocarditis

JAMA Internal Medicine

Several recent case series have described acute myocarditis after COVID-19 messenger RNA (mRNA) vaccination. While the cardiac complications of vaccines are important, discussion has been limited by small sample sizes that lack gender and racial and ethnic diversity. 414 fully vaccinated individuals). women and 31.2%

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