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Argentina Follows UK In Backing Oxford/AstraZeneca COVID-19 Vaccine

Thumbs-Up From Mexico Is Imminent

 
• By Kevin Grogan and Maureen Kenny

While the US and EU regulators seem less than keen on the data package offered to date on COVID-19 Vaccine AstraZeneca, Latin American countries are moving quickly to follow the UK in backing the cost-effective and more-easily deliverable option.

az vacc
Vaccines Are Seen As Key In The Fight To Control The Pandemic • Source: Shutterstock

While debate about the data behind AstraZeneca PLC and Oxford University’s COVID-19 vaccine continues in Europe and the US, countries in South and Central America seem happy to follow the UK's lead and grant temporary authorization to the product which has been hailed as a game-changer globally to tackle the coronavirus pandemic.

The UK’s Medicines and Healthcare products Regulatory Agency granted emergency approval for COVID-19 Vaccine AstraZeneca, formerly known as AZD1222, on 30 December based on interim efficacy and safety data from Phase III trials conducted in the UK and Brazil

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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
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More from Product Reviews

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

PharmaMar Seeks EU Fast-Track Status For ‘Practice-Changing’ ES-SCLC Therapy

 
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US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts

 
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Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.