As cases rise, Europe plans to delay second coronavirus vaccine – POLITICO

Faced with the surge in coronavirus cases, some European countries are considering changing course and joining the UK to vaccinate as many people as possible with a single dose rather than the two given so far in clinical trials.

This issue has been online since December 30, when the UK announced its decision to delay second doses for up to 12 weeks when it approved the Oxford / AstraZeneca vaccine for emergency use. The switch also applied to the BioNTech / Pfizer jab.

Just this week, Denmark announced its decision to postpone the second dose of Pfizer and upcoming Moderna jabs for six weeks. The German health ministry has also confirmed that it plans to expand vaccine coverage through similar delays between doses.

Meanwhile, the US federal government is in talks with Moderna to halve the recommended dose of the vaccine to speed up vaccination efforts.

Scientists are divided. Some argue that delaying could cause other viral mutations and make the shot ineffective. Others question whether recipients will be left more vulnerable, pointing out that allowing for larger spreads between doses has not been tested properly.

The pro-retard camp argues that an immediate level of broader protection, albeit slightly lower, is better than stronger protection for half as many people. UK Deputy Chief Medical Officer Jonathan Van-Tam made the point in Sunday’s Mail, saying maximizing coverage with the first dose “will save lives.”

Belgium’s leading epidemiologist, Pierre Van Damme, also supports the idea of ​​discontinuing the dosage. Speaking to broadcaster VRT last week, he said the strategy would quickly provide protection to more people and “herd immunity would increase at a much faster rate. (Belgian Health Minister Frank Vandenbroucke has asked the vaccine task force to examine the possibility of delays between doses, but has not yet made a statement, his spokesman warning that he does not there was still not enough evidence for this decision.)

As vaccine stocks run out and the new British and South African coronavirus variants are alarming – made worse by overburdened health systems – some politicians are now siding with the latter camp.

The catch: While the UK’s approach has been developed and supported by many public health scientists, it lacks the rigor of the controlled testing in which the UK is so familiar.

Not fully tested

The idea of ​​vaccinating as many people as possible with the Oxford / AstraZeneca vaccine before its approval for emergency use was first floated by former Prime Minister Tony Blair in early November. It was quickly rejected by doctors and scientists on the grounds that it would miss out on the controlled clinical trials already underway for these treatments. These studies ultimately ruled out the therapeutic winners (dexamethasone) from the losers (hydroxychloroquine).

The debate changed again this week when the British Society for Immunology lent a hand on Monday. While their statement placed “the greatest value on an evidence-based approach to medical decisions”, they called for a “short-term pragmatic approach” given the “unprecedented situation”. The Company has supported the delayed two-dose schedule – provided the government develops a “robust immune surveillance program.”

Sheila Bird, former program manager at Cambridge University’s MRC Biostatistics Unit, went even further. In an emailed statement on Monday, she called on the UK to randomize standard and delayed dosing schedules in order to compare the effectiveness of the two approaches.

“Trials would be good for all of these variations, although the data we have shows very good protection against a dose of AstraZeneca or Pfizer. [vaccines]… The speed and scale of vaccination is crucial for success, ”said Professor John Bell of the University of Oxford, also a member of the UK Vaccine Task Force, in an email.

Unique data

In their defense of delayed doses, the UK’s chief medical officers pointed to data showing that the short-term vaccine effectiveness from the first dose is around 90% with the BioNTech / Pfizer vaccine and around 70% with the Oxford / AstraZeneca vaccine. The second dose is likely to be “very important for the duration of protection,” they said in a joint letter dated December 31.

Some scientists, however, remain concerned whether efficacy may decline beyond the three and four week periods indicated for the second doses of the Pfizer and AstraZeneca vaccines, respectively.

Data from the British Society for Immunology on the BioNTech / Pfizer vaccine, for example, shows that antibodies and T cells are neutralized more effectively after the second dose. The company also notes that “Likewise, the Oxford / AstraZeneca vaccine shows substantial immunological differences after the second dose at 28 days”.

They concluded, however, that delaying a second dose for eight weeks “would be unlikely to have a negative effect on the overall immune response after the boost.”

Peter English, former editor of Vaccines in Practice magazine and former chairman of the British Medical Association’s Public Health Medicine Committee, also made the case for the delays. In a Monday editorial, he wrote that decades of experience with other vaccines have shown that, if appropriate, “increasing the interval will improve the quality of the booster response.”

A single dose approved ahead?

With Johnson & Johnson investigating the matter in a large clinical trial, more data on the effectiveness of a single dose and the duration of protection will likely be revealed by the end of the month.

Like the Oxford / AstraZeneca vaccine, the J&J vaccine is based on adenovirus viral vector technology. This uses a modified cold virus to carry information into cells, telling them to make advanced protein antigen in order to create an immune response.

J&J, who has experience immunizing against the pandemic after the successful approval and launch of its Ebola vaccine, said in November that while a single-dose vaccine “would have significant benefits, particularly in the context of pandemic ”, the company’s vaccination program is also testing two. doses in a separate trial.

The first unpublished results from a first-stage clinical trial showed that a single dose is effective in generating enough antibodies in 98% of patients after 29 days, the company said.

Pending positive results, the US drugmaker plans to file global licensing applications with data supporting the one-dose schedule. The European Medicines Agency hopes to reach a decision in March.

Last hurdle

The British approach allows the off-label use of Pfizer and AstraZeneca vaccines, which means that these vaccines can be administered outside of their authorized indication without consequences. This is possible thanks to the instructions of the Joint Committee on Vaccination and Immunization, which offers protection against retaliation.

The same does not apply elsewhere in Europe, where countries will use vaccines approved by the EMA.

“I don’t think healthcare professionals … in the EU would approve or otherwise be inclined to promote any kind of off-label use,” said Vincenzo Salvatore, lawyer at Bonellei Erede and former legal director of the EMA.

“Any modification of [administration] would require a modification of the marketing authorization, “the EMA said, as reported by Reuters,” as well as more clinical data to support such a change. Otherwise, it would be considered ‘improper use’. “

Vaccine makers have also championed clinically approved indications.

“Our Phase 3 clinical trial and emergency use authorization in the United States are associated with 100 ug in two doses, 28 days apart,” a Moderna spokesperson said in an e- mail, regarding half doses in the United States.

BioNTech echoed this sentiment in the FT, reiterating that no data exists to support the administration of two doses of its vaccine given more than 21 days apart.

English, who is also a communicable disease control consultant in the UK, said the vaccine committee had the advantage of “seeing people and needs at a glance.” It includes decades of knowledge about vaccines, the immune system and how they interact – “not just from the trials that have been done to obtain the license.”

He also warned of the deadly risk of limiting factors affecting such decisions.

“People are divided between those who want explicit, narrow and direct empirical evidence and those who are prepared to extrapolate from circumstantial evidence,” he said. “The problem is, lives could be lost if we wait for the narrow direct evidence.”

Charlie Cooper, Hans von der Burchard and Camille Gijs contributed reporting.

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