- AstraZeneca’s Covd-19 vaccine trial was considered a leading candidate, but was recently put on hold after participants became ill.
- The trial was reviewed by an independent committee and judged the safety of the jab before resuming this week.
- In addition to the suspension, South Africa’s Covid 19 cases are declining, so local courts are unlikely to see this year’s results.
The results of the Covid-19 vaccine trial at AstraZeneca, a South African pharmaceutical company, are likely to be postponed until early next year, said Shabir Madhi, a South African principal investigator in the study.
The study in all four countries under study, including South Africa, was stopped last week due to the side effects of one of the UK study participants.
Investigations in the United Kingdom, the United States, Brazil and South Africa resumed in the United Kingdom on Sunday, with the National Regulatory Authority’s Ethics Committee, the South African Health Products Regulator (Sahpra), an independent safety commissioner appointed by AstraZeneca. We reviewed the findings of the association.
“I expected to get an answer by the end of November about whether the vaccine would work, but now it’s very unlikely.” Professor of Vaccination at Witz University and South African Medical Research Council (SAMRC) The Meningeal Pathogens Research Unit says.
“The trial was short-lived, but we’ll probably only get answers in the first quarter of next year.”
The vaccine candidate, known as AZD1222, was developed in collaboration with the Jenner Institute at Oxford University and Thought Europe is already with many becoming front runners of potential candidates 400 million doses by the end of the year.. The first Covid-19 vaccine trial to reach Africa- South Africa registered its first participant on June 24th..
AstraZeneca does not publish information about the condition of patients who discontinued the study, but it is widely reported. The patient in question was a British woman Rarely accompanied by neurological symptoms consistent with transverse myelitis, a serious spinal cord inflammatory disorder.
Transverse myelitis interferes with messages sent by the spinal nerves throughout the body, according to the research institute Mayo Clinic. body.. This can cause pain, weakness, paralysis, sensory disturbances, or bladder and bowel dysfunction.
However, an independent Data Safety Oversight Committee said, “It is unlikely that the adverse event was due to vaccination,” Maddie said. Daily Maverick Webinar on Sunday.
Approximately 90% of South African participants-1800 out of 2,000-participate in the trial, of which approximately half receive placebo and the other half receive candidate vaccines.
South Africa’s SARS-CoV-2 infection rate (the virus that causes COVID-19) is much slower than when local trials began in June, which also takes time to investigate, according to Maddy. The required result.
To be able to analyze whether the AZD1222 vaccine is effective, Maddy and his team need that at least 42 of the 2,000 study participants have developed Covid-19.
Vaccine researchers set the “endpoint” or “result” of the study. This helps you calculate the number of people you need to register by using carefully considered assumptions and statistical formulas.
Next, we look at the number of cases of infection needed to determine if the vaccine being tested can be considered effective beyond mere coincidence. For this study, the trial should result in at least 42 “results” or infections among all participants.
The South African clinical trial is part of an advanced phase of the AstraZeneca clinical trial known as Phase 3. Clinical trials traditionally go through several stages, starting with laboratory and animal studies, to ensure that they are functional and safe.
If the immune response to the virus gives a positive result at this stage, the study can proceed to human testing. stage.. Each step grows larger and fine-tunes details such as the correct dosage required. Phase 3 is the final step before seeking regulatory approval for the vaccine to work.
Maddy says it’s not uncommon for trials to be suspended for safety reasons. “The reason for the news now is due to Covid-19.”
However, Mitchell Warren, executive director of AVAC, a US-based advocacy organization, hopes that the Covid-19 vaccine (a vaccine that typically takes 10 years to develop) is making rapid progress. Everyone lives in Covid’s urgency, fear, and anxiety at this moment, everywhere, and we are all seeking vaccines.
So we want to go as fast as we can, but that speed must not come at the expense of the scientific process, “he says.
Maddy says that if the AZD1222 vaccine turns out to be effective, it is likely to result in “the same type of immunity as a natural infection.”
“We still don’t know how long the immunity will last, but in the experience of the common cold coronavirus, the immunity lasts for about 2-3 years, so reinfection can occur, but 2 of the infection. The second episode is less severe than the first episode. “
Vaccine testing in South Africa does not necessarily make countries more accessible to such products, but it does provide data on whether vaccines can be used safely and effectively in our environment. And Linda-Gail Bekker Deputy Director Desmond Chuchu HIV Center.
Becker will serve as a local executive alongside Glenda Gray, president of SAMRC for vaccine trials at pharmaceutical companies Johnson & Johnson.
Phase 3 investigations will begin later. Moon..
South Africa is also currently recruiting participants for Phase 2 vaccine trials at pharmaceutical companies. Novavax..
According to Maddy, the Covid-19 vaccine, which tested positive in the epidemic, could be introduced in some countries for emergency use before it was approved and approved by regulators. There is sex.
“But it wouldn’t be unique to Covid D-19. It was also done with the Ebola vaccine in the Democratic Republic of the Congo and West Africa.”
Image Credit: AstraZeneca
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