U.S. and European pharmaceutical industry organizations on Wednesday urged governments not to extend the delays prescribed by COVID-19 vaccine developers between the first and second shot, as the U.K. has begun to do to deal with current bottlenecks or shortages.
- Governments and national health authorities should “stick to the dosing that has been assessed in clinical trials,” said the European Federation of Pharmaceuticals Manufacturers and Associations, the U.S. Biotechnology Industry Organization, and the Pharmaceuticals Research and Manufacturers of America, in a joint release.
- Any change in dosing or schedule “should follow the science and be based on transparent deliberation of available data,” they added.
The U.K. government earlier this year devised plans to extend the interval between two doses to up to 12 weeks, against the minimal three weeks prescribed by manufacturers, triggering criticism from BioNTech
a developer of the first vaccine to be approved. Other countries, such as Germany, are considering similar steps.
The World Health Organization said last week that although “an interval of 21 to 38 days” was recommended for the vaccine developed by BioNTech and U.S. drug company Pfizer
that could be extended up to 42 days (six weeks)” due to the current “exceptional circumstances.”
- The U.S. Food and Drug Administration, on the other hand, said on Jan. 4 that “changes to authorized dosing or schedules” would be “premature and not rooted solidly in the available evidence.” Barring appropriate data, it added, this would represent a “significant risk of placing public health at risk.”
- The European Medicines Agency has also expressed its skepticism on an intervals extension.
The outlook: The U.K. decision, triggered by the severity of the COVID-19 pandemic spike and the ambitious vaccination campaign the government has set, is now coming under fire from the pharmaceuticals industry. That could increase fears among the public about the risks of a rushed vaccination campaign, with a negative impact on confidence that would nullify the benefit of vaccinating more people faster.
The industry reaction is also a way of warning governments that vaccine developers cannot be held responsible in the future for incidents or adverse side effects during vaccination campaigns that would not have followed strictly the recommended doses and schedules.