Switzerland REJECTS AstraZeneca coronavirus vaccine, citing lack of sufficient data to prove effectiveness

The main medical regulator of Switzerland has rejected the Oxford-AstraZeneca Wuhan coronavirus (COVID-19) vaccine. According to the regulator, there is a lack of available trial data to prove that the vaccine is safe to use.

“With regard to the AstraZeneca vaccine, the data submitted and analyzed so far are not yet sufficient to permit authorization,” said the Swiss Agency for Therapeutic Products (SwissMedic) in a statement released on Wednesday, Feb. 3.

“To obtain more information about safety, efficacy and quality, additional data from new studies are needed.”

The Human Medicines Expert Committee, an external and independent advisory panel that double-checks SwissMedic’s findings on medicines for human use, arrived at the same conclusion during a meeting on Tuesday.

“The data currently available do not point to a positive decision regarding benefits and risks,” said the panel. SwissMedic concluded its statement by demanding more data.

“To obtain a conclusive assessment, the applicant will, among other things, have to submit additional efficacy data from a Phase III trial underway in North and South America, and these will have to be analyzed. As soon as the results have been received, a temporary authorization according to the rolling procedure could be issued at very short notice.”

AstraZeneca responded by saying it will continue to share new data with SwissMedic “as it becomes available,” and will comply with every requirement to make sure its vaccine is approved.

“AstraZeneca has now been granted a conditional marketing authorization or emergency use in close to 50 countries, spanning four continents, including most recently in the European Union,” said the company in a statement. “We are confident that our vaccine is effective, well-tolerated and can have a real impact on the pandemic.”

Many in Switzerland expected the Oxford-AstraZeneca vaccine to be approved, especially since it has already been given authorization for use in the United Kingdom where it was developed, and in the European Union. But health officials in several European countries have advised against its use, especially for older people. These countries include Poland, Sweden, Italy, Germany and France.

Meanwhile, other countries have set cut-off ages for people who wish to take the vaccine. For example, Ireland has set its cut-off age at 70, while Belgium has it at 55.

The European Medicines Agency said there is not enough data to provide a faithful estimate of the vaccine’s efficacy for people over the age of 55. Therefore, it cannot reliably justify its use for people over 55. (Related: Aussie scientists cast doubt on low-efficacy AstraZeneca coronavirus vaccine.)

Switzerland far behind its European neighbors in immunization

Despite Switzerland spending more on healthcare than any other country in Europe, Swiss officials are still concerned over the slow pace of their coronavirus vaccine rollout.

According to a guidance released in December 2020, the Swiss government plans to vaccinate at least six million people – or nearly three-quarters of the entire Swiss population – by summer of 2021. As of Jan. 31, the country has only administered around 315,000 doses (3.7 percent of the population) of the vaccines it has approved (BioNTech-Pfizer and Moderna).

While this is marginally higher than the average for all 27 member-nations of the EU, it is only a fraction of the U.K.’s 15 percent. It is also far less than Serbia’s, which has inoculated 6.8 percent of its population. Serbia is not a member of the EU and has less than a tenth of Switzerland’s gross domestic product per capita.

The Swiss government’s vaccine rollout plan is drastically behind schedule. Authorities will have to administer over 70,000 doses per day to meet its target. It is unlikely that the country will reach its goal, as it is dealing with a shortage of coronavirus vaccines. Authorities in the capital of Bern had to shut down immunization appointments over the weekend due to a lack of doses.

“The government’s vaccination plan has failed,” said Marco Chiesa, leader of the country’s largest conservative party, the Swiss People’s Party. “We are not used to such unreliability.”

According to Interior Minister Alain Berset, whose department oversees the procurement of vaccines, shortfalls in delivery are expected to be fixed by March. Berset added that the country will most likely miss its target of inoculating everybody over the age of 75 by the end of the month. However, Berset remains optimistic and said all adults will be vaccinated by the end of June.

Government officials are pinning the blame for this slow rollout on a lack of infrastructure. The country is not set up for the kind of swift decision-making required for vaccine procurement. Furthermore, the country did not provide any funding for vaccine development, which would have given it a bigger priority in terms of vaccine acquisition.

“The EU supported the financing of production facilities and we didn’t do that,” said former health ministry official Andreas Faller.

A spokeswoman for the Swiss public health office said the country has no legal basis for investing in virus research or domestic vaccine production. “The federal government doesn’t do investment policy,” she said.

Even if the country procures enough vaccines, it has to deal with a skeptical population. According to a survey conducted by the University of Zurich at the beginning of January, only around 50 percent of the population said they were willing to receive the coronavirus vaccine. A full one-third of the populace said they would refuse to take the vaccine.

Learn more about the dangers of the Oxford-AstraZeneca vaccine by reading the latest articles at VaccineDamage.news.

Sources include:

FT.com

SwissMedic.ch 1

SwissMedic.ch 2

Politico.eu

Bloomberg.com