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Coronavirus Notebook: Leading Vaccines Near Approval, EU Signs More Advance Purchase Deals

Developers Are Under Pressure To Share Their IP And Reveal Costs

 
• By Ian Schofield

Health activists are stepping up the pressure on COVID-19 vaccine companies to share their IP and reveal their costs, while the European Medicines Agency has published regulatory guidance advising vaccine developers to aim for a point estimate of efficacy of at least 50%.

ampoules with Covid-19 vaccine on a laboratory bench. to fight the coronavirus / sars-cov-2 pandemic
Two COVID-19 vaccines are nearing approval • Source: Shutterstock

Things are moving fast on the COVID-19 vaccine front, with the leading candidates showing impressive results in late-stage trials and two expected to be approved for use as early as next month.

On 16 November, Moderna, Inc. announced a 94.5% efficacy rate for its mRNA-1273 product in the Phase III COVE trial. In doing so, it outshone both the Pfizer Inc./BioNTech SE and Sputnik V coronavirus vaccines, which just days earlier had reported protection rates of 90% and 92% respectively

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More from Europe

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

More from Geography

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.