The company has suspended tests of a promising covid vaccine. It is proof that control mechanisms work, experts react

The American pharmaceutical company Johnson & Johnson announced the temporary suspension of covid-19 vaccine research on Monday. She said in a statement that one of the study participants had unexplained health problems.

The difficulties that a participant in a clinical trial began to suffer from are now being investigated by an independent committee and Johnson & Johnson physicians. Because this is a double-blind study, the researchers themselves do not know whether a patient with these unspecified problems received a vaccine at all or just a placebo. Therefore, a third, independent party needs to enter the investigation.

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The final phase of testing was launched by the American company on September 23. According to the DPA, it is attended by 60,000 volunteers from three continents. Johnson & Johnson hopes the vaccine could be available early next year. While most manufacturers anticipate that covid-19 vaccine will need to be administered in two doses, with Johnson & Johnson, only one dose should be sufficient.

The company emphasized that the clinical trials themselves were not interrupted; According to her, various similar problems are an expected part of the research. Under normal circumstances, it would not even inform about the interruption of the research (yes about the interruption of the clinical study), but it wants to inform as much as possible about the development of the covid vaccine due to its importance. She did not disclose details about the patient’s problems due to the protection of his privacy.

Last week, the European Commission signed a preliminary contract to buy vaccines with Johnson & Johnson, which will provide member states with the purchase of 200 million doses. The EU will have a pre-emptive right to the same amount thanks to the contract. Similar contracts have been concluded by the Commission with Sanofi-GSK and AstraZeneca.

AstraZeneca, like now Johnson & Johnson, suspended clinical trials of its vaccine in early September. Also in this case, one of the participants developed unexplained health problems. After a few days, however, the company resumed testing the vaccine, which it is developing together with Oxford University.

Last week, the Czech government released 150 million crowns for the purchase of three million coronavirus vaccines contracted by the European Union.

Suspended testing proves that the mechanism works

Suspension of clinical trials of new drugs is relatively common. But now he is receiving extra attention due to the world’s interest in the development of the covid-19 vaccine. In addition, Eli Lilly announced on Tuesday that it was suspending testing of a promising anti-covid drug.

Eli Lilly is testing the Ly-CoV555 monoclonal antibody in the ACTIV-3 test, which was part of a therapeutic cocktail that President Donald Trump received in October when he contracted a new coronavirus. Tests examine its effectiveness in combination with remdesivir or placebo.

Unlike vaccines, the scope of testing in this case is small, affecting a maximum of hundreds of patients.

According to the professional medical website STAT NEWS, the suspension of vaccine and drug development is good news – it shows that control mechanisms work and companies try not to rush production and not endanger patients.

How are the other vaccines?

The World Health Organization (WHO) said in February this year that the covid-19 vaccine would not be available for 18 months. WHO chief Tedros Adhanom Ghebreyesus said in early August that the vaccine would require a hundred billion dollars (2.3 trillion crowns), and noted that despite hopes of being available soon, covid-19 may never be there should be a “miracle panacea”. Last week, however, Tedros suggested that the vaccine could be ready by the end of the year. “We need vaccines and there is hope that we may have a vaccine by the end of this year,” Tedros said.

The WHO, in collaboration with the World Vaccination Alliance GAVI and the world’s leading vaccine research and development organization CEPI, has initiated the international COVAX project, which aims to distribute two billion vaccines worldwide by the end of 2021. You have to get health workers first and then the most vulnerable people in every country, regardless of wealth. The project involved 170 countries, including 76 rich countries, including China, but lacking the United States and Russia.

According to the WHO, at the beginning of October, 42 vaccine candidates were in clinical trials and 151 vaccine candidates were in preclinical trials. In the last, third phase of the studies, the WHO lists ten vaccines. Manufacturers usually estimate the date of their launch from the end of this year to the middle of next year, depending on the success of testing.

The most promising projects

So far, the aforementioned AstraZeneca vaccine, which was created in collaboration with experts from Oxford University, is the furthest in the approval process.

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The vaccine is also being developed by the American pharmaceutical company Pfizer in cooperation with the German biotechnology company BioNTech. At higher doses, some patients also had side effects when tested, but according to researchers, they were not very serious. This vaccine has also entered the third phase of testing.

One of the most promising substances against covid-19 is then being developed by the American biotechnology company Moderna. It entered the last phase of testing, in which 30,000 volunteers are tested at the end of July. Other vaccines under development in the third phase of testing include substances from the Chinese Institute of Biological Products in Wuhan and Beijing, the Chinese pharmaceutical company Sinovac, which tests on volunteers in Brazil, and the American company Novavax, which also has a production plant in the Czech Republic. and the vaccine will also be tested by Czech citizens.

In the third phase of clinical trials, there is also a Russian vaccine called Sputnik V, which is being tested in Venezuela. The substance, developed by the Moscow Institute of Epidemiological and Microbiological Research of Nikolai Gamaleji, was announced in August by Russian President Vladimir Putin as the first officially completed in the world. However, the extent and sufficiency of previous vaccine tests has been questioned by Western experts.

The Czechia is also trying to produce its own vaccine against covid-19, and the State Institute of Public Health is cooperating with the Institute of Hematology and Blood Transfusion and the Institute of Clinical and Experimental Medicine in its development. The results of its first phase of testing will be assessed by experts from the Czech Vaccinological Society.

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