Luxembourg currently only accepts certificates of vaccination with vaccines approved by the European Medicines Agency (EMA). For Paulette Lenert, Luxembourg’s health minister, the solution is to “redo a full vaccination.”
The Indian manufactured vaccine has conditional marketing authorisation in a number of countries like Iran, Zimbabwe, Nepal, Mexico, Philippines, Guatemala, Nicaragua, Guyana, Venezuela and Botswana. In November, 2021, the World Health Organization (WHO), included it on its emergency list of covid-19 vaccines.
“The number of clinical studies on the efficacy and safety of the vaccine remains limited,” the health minister said in answer to a parliamentary question. However, this is the case with all emergency authorised vaccines.
The European Medicines Agency (EMA) does not recognise Covaxin and no request for European marketing authorisation has been introduced to date. Recognition of vaccination certificates with Covaxin had been discussed at European level, and in particular on 8 December 2021 at the Health Security Committee.
During the committee, ten EU member states recognised non-EMA vaccines, accepting vaccination certificates based on the Covaxin drug, but sixteen countries did not accept them--Luxembourg being one of them.
Therefore the health ministry has recommended “for people staying for a prolonged period in the national territory” to undertake another full vaccine scheme for their CovidCheck certificate. “This does not pose a health risk to the persons concerned,” according to the health ministry.
“There is no data” on people receiving several vaccination schedules, said Dirk Brenner, an immunologist at the University of Luxembourg and the Luxembourg Institute of Health. In his opinion, successive vaccination would not cause potential health problems. Pointing to Israel, which boasts a high vaccination rate and is on its fourth dose, Brenner said the side effects were similar to lower doses.
The EMA recently stated that too many booster shots risk damaging and reducing the efficacy of an individuals immune response. “I don’t believe this is true,” Brenner said, adding: “If you stimulate the immune system, let it calm down, wait two or three months and give a booster. The immune system will react in the normal way.” Even six doses would be “totally fine.”
Pharmaceutical giants have been reluctant to share the raw data from their clinical trials, not only when it comes to the covid-19 vaccine. A regional director with 15 years’ experience in clinical research coordination and management who lasted two weeks working for Ventavia, a company managing vaccine trials for Pfizer, (BMJ) that “speed may have come at the cost of data integrity and patient safety” and that “the company falsified data,” while also revealing the company “was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.”
Pfizer has not commented on the whistleblowers allegations but Ventavia told The Conversation last year: “The accuser was employed for approximately two weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. The allegations were investigated and determined to be unsubstantiated.”