Switzerland Nixes AstraZeneca Vaccine Until More Evidence Is Obtained. Other EU Countries Rule Out Vaccine For Older People Medicines & Vaccines 04/02/2021 • Madeleine Hoecklin Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Switzerland was unable to approve the Oxford AstraZeneca COVID-19 vaccine, requiring additional efficacy data. Switzerland has become the first European country to reject an application by AstraZeneca for regulatory approval. Meanwhile, half a dozen other European countries have now said that data on the AstraZeneca/Oxford vaccine so far is insufficient to permit its use among people over the age of 65 – with Belgium being the latest. “The data currently available do not point to a positive decision regarding benefits and risks,” said the Swissmedic press release, issued Wednesday explaining the thumbs down given to the AstraZeneca vaccine – regardless of age. “To obtain a conclusive assessment, the applicant will among other things have to submit additional efficacy data from a Phase III trial under way in North and South America, and these will have to be analysed,” said Swissmedic. Swiss Health Minister Alain Berset said that the regulatory decision would not crimp vaccine rollouts: “I think it does not affect the vaccination strategy” he said. Switzerland recently signed a contract with Moderna for an additional six million vaccine doses on top of the 4.5 million already purchased. Those, along with 3 million Pfizer vaccines would be enough to vaccinate almost every adult in the country. Switzerland also has pre-orders for another six million doses of vaccines by Novavax and five million doses from CureVac, whose vaccine is in late stage development, and the Swedish government. Nora Kronig of the Federal Office of Public Health said recent purchases would thus offset the decision on AstraZeneca. Still she was reluctant to commit to a timetable for the next phases of vaccine rollout, saying only: “We are reluctant to make predictions because that depends on various factors. What can be said is we are on track, with the new contracts we can achieve our goal by the end of summer.” Approval of the AstraZeneca and Johnson & Johnson vaccines depends on the quality of the documents still outstanding. It is thus difficult to predict the approval date. The rolling procedure means a decision can be made as soon as all the necessary information is available. — Swissmedic (@Swissmedic_) February 3, 2021 Contracts notwithstanding, Switzerland’s vaccine rollout so far has been lackluster – with only about 3.7% of the population inoculated, according to Bloomberg’s global vaccine tracker. That’s marginally more than the average for the 27-member EU, though a fraction of the UK’s 15%, and less than frontrunner Serbia, which is not an EU member. Switzerland got off to a relatively late January start to vaccines, while Pfizer and supply chain constraints have also been a factor, like elsewhere in Europe. Clement Beaune, French European Affairs Minister, defended the slower vaccine rollout rate across much of Europe compared to the United Kingdom, claiming that the UK took fewer precautions in using AstraZeneca’s vaccine in older individuals without sufficient data. World map of COVID-19 vaccinations. More than 108 million doses have been administered in 67 countries. Six EU Countries Now Nix the AstraZeneca Vaccine For Older People – Running Against EMA Advice That It Was OK In the EU, meanwhile, Belgium has joined France, Poland, Sweden, Germany and Italy in advising against the use of the Oxford/AstraZeneca’s COVID-19 vaccine in people over the age of 65, due to the lack of data on its efficacy among people in this age group. The decisions mark a departure from the European Medicines Agency (EMA) recommendations which on 29 January granted the Oxford/AstraZeneca vaccine a conditional authorization – including for older participants, stating: “Protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines…EMA’s scientific experts considered that the vaccine can be used in older adults.” But one after another national health authorities have cited the need for additional clinical trial data on older individuals – which is expected to come out of an ongoing Phase 3 trial in the United States. French President Calls Vaccine “Quasi-Ineffective” for People Over 65 Speaking to reporters last Friday, French President Emmanuel Macron said, “Today we think that [the AstraZeneca vaccine] is quasi-ineffective for people over 65.” “What I can tell you officially today is that the early results we have are not encouraging for 60 to 65-year-old people concerning AstraZeneca,” he added. “Currently available data for people aged 65 and over are limited by a small sample size and don’t allow for a conclusion on the safety and efficacy of the [AstraZeneca] vaccine for this population,” said the French health authority (Haute Autorité de Santé (HAS)). “The HAS recommends using the AstraZeneca vaccine in people under 65, starting with professionals in the health sector…and people aged 50 to 64 with co-morbidities.” Poland set an even lower threshold of 60 years of age for the AstraZeneca vaccine, while Italy and Belgium advised against its administration to those older than 55 years old. “The superior health council says very clearly that the AstraZeneca vaccine is a very good vaccine for people between 18 and 55 years old,” said Frank Vandenbroucke, Belgium’s health minister. “But it also said we don’t have enough data today to say with certainty that it works so well in older people.” “Maybe we will have the necessary data in a few weeks. For the time being we are taking it safe,” he added. Germany was the first to recommend an age restriction for the Oxford/AstraZeneca vaccine – a move that prompted discussions about reordering vaccine priorities – which placed older people high up on the list. “On the one hand, we have to immediately procure alternative vaccines for people over 65 and on the other hand, we have to re-coordinate the vaccination sequence for the AstraZeneca vaccine that will arrive shortly,” said Saskia Esken, co-leader of the Social Democratic Party of Germany (SPD). But for now, people over the age of 65 as well as residents in nursing homes will not be able to be vaccinated with the AstraZeneca vaccine. This will potentially delay the goal to vaccinate all nursing home residents by mid-February and all people over 80 years old by the end of March. United Kingdom Meanwhile Rolling Out For Older People – AstraZeneca Says Strong Antibody Protection Demonstrated An NHS worker in North London receives her first dose of the Oxford/AstraZeneca vaccine on Monday 4 January. The UK, which authorized the AstraZeneca vaccine for emergency use already at the end of December, has already begun rolling it out for older individuals. AstraZeneca acknowledges that less than 10% of the participants in clinical trials were over the age of 65, reportedly because Oxford University researchers were waiting for sufficient safety data in the 18 to 55 age group before vaccinating older people. “We don’t have a huge number of older people who have been vaccinated,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The AstraZeneca vaccine has also been approved for all age groups by India, Mexico and Argentina. Image Credits: Bloomberg, Andrew Parsons. 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