(MENAFN – IANS) 
Le arul louis
New York, 25 February (IANS) How is the safety and efficacy of the COVID-19 vaccine ensured?
I volunteered for a trial of the Oxford-AstraZeneca vaccine and saw just how scientists and doctors make sure it is safe and effective before it is released to everyone.
The Oxford University – developed vaccine developed by the Serum Institute of India under the Covishield brand name began in India last month as part of the world ‘s largest vaccine program, and in dozens of countries. four continents.
It was already a key step in the British anti-coronavirus campaign.
I entered the exam with New York University’s Langone Vaccination Center in New York City, where I am based as a U.S. journalist for IANS, and received two test injections.
It is a Phase III test with approximately 30,000 volunteers who have followed two limited trials and is similar to the detailed tests conducted in India, Britain, Brazil and elsewhere.
Mark J. Mulligan, director of the vaccine center, said the license can be relied upon based on the tests as the data will be reviewed by independents from non-company physicians. deciding whether it can be used.
Although the development of the vaccine and the tests have progressed very quickly, their safety will not be compromised, he said.
“Normally, this process would take years but with so many diseases right now we can get the response quickly. So we can move to emergency use authorization,” he said.
The study I am in is a double-blind test, with two in three volunteers receiving the vaccine themselves and the other a placebo as a “sensitive injection of harmless salt water – it is not known who found them. I won’t know if I found the real one until the review is over, maybe next month.
Mulligan explained the need for the double-blind study where some volunteers receive the placebo.
“We use the design under blind control, so that we can answer the question,‘ Is the vaccine protected, (those who receive the vaccine) compared to a control group ( is not) ‘? “he said. “It’s really the only way we can find out if new medical interventions are really effective and, in fact, say we’re looking at safety all the time.”
The reason is not to let the participants if they were getting the real one or the placebo, if someone knew that they had received the vaccine they could be behaving themselves there the different way of wearing the mask or being exposed to big people, he said.
After receiving the first injection, I had only a slight fever, a sore arm where I got the bullet, fatigue and a very mild rash on my shoulder. They left in a day.
But that certainly does not mean that I actually received the vaccine as it may be a psychotic response as a subconscious response even though I did not receive it based on what I read most there should be side effects.
After the second look, there was a similar reaction to me, except for the rashes.
Mulligan said, “I like to tell my study volunteers and my patients that it ‘s a good thing when you get those vaccine reactions. It means you get a strong response to the vaccine and it’s not a safety concern at all. “
The study collects data in three ways to make it safe and effective.
A doctor and a nurse in the program interview me from time to time to check for feedback.
They also collect my blood at times to determine if the vaccine has been effective in secreting the antibodies. In fact, the program has recorded blood transfusions for me over a two – year period to determine how effective the vaccine is.
Each week I also have to fill in an electronic diary about my health status and if I have COVID-19 symptoms, which I did not get. (Even a COVID-19 test that I took independently outside of a vaccine testing program was a condition for attending a negative event.)
Before I received the first dose, vaccine test staff took down my medical history and a doctor gave a physical exam so that they would have a status to compare any changes later.
“We always look at our clinical trial volunteers as heroes because you know you are working for the good of humanity to help us overcome the pandemic,” he said. Mulligan.
While I wanted to contribute to the development of the vaccine, I did not think there was a personal risk to me in the trial because the participants in the first two stages had determined that there was no safety risk. It is on them that I consider the true heroes, especially those in the first test; they took the real risks, not me.
Mulligan said that before the human trials began, a lot of preliminary work was being done in the laboratory and with small animals. Once it is established that the vaccine is likely to be safe and effective, manufacturers will seek permission from the U.S. Food and Drug Administration to conduct human testing. In India, the trials are authorized by the General Drug Control Agency (CDSCO).
A Stage I test usually involves between 50 and 100 people “and is actually designed to give a small number of people to the vaccine to make sure it’s safe,” Mulligan said. He is “aiming for safety but starting to look at the immune response and if everything looks good in step one you will progress to Stage II”, he said.
In Phase II there may be between 200 and 500 registered people and if it confirms the safety and security response seen in Phase I, the tests will move to the next stage where thousands are registered. With a very strong evidence base for safety, “in Stage III you ask an important question, ‘Does the vaccine protect’?” He said.
The participants in the experiment were selected to reflect the diversity of the population, including race, ethnicity and age. They also had to make some exposure to the disease rather than be on their own, and in my opinion it covered meetings and complaints.
Mulligan pointed out that it is important to know that the authors of emergency use for vaccines are not the same as a full license or license.
“They say that, based on the completeness of the evidence available, we believe that the safety and benefit is so great that it is reasonable to use these vaccines in a public health emergency,” he said. e.
The companies will still have to apply for a full license down the road and will continue to collect safety response protection data and report them to the regulatory authority, he said.
The Oxford-AstraZeneca vaccine, which has received emergency use approval from the World Health Organization and dozens of countries, has the potential to be a game changer in the global fight against COVID-19 pandemics.
“It’s a very important vaccine,” Mulligan said because of “easier storage (at 4 levels) but also because it can be taken in large numbers. AstraZeneca said it can produce up to 3 billion doses this year. “
In India alone, the Serum Institute of India has a target of 1.5 billion doses this year and the capacity is expected to increase to 2.5 billion annually by the end of the year.
In addition to Covishield to the Indian government for domestic vaccines and donations to other countries, the Serum Institute, according to the WHO, is expected to deliver 240 million doses in the first half of this year to COVAX, the vaccination campaign global for developing countries.
The first passengers under the COVAX program were delivered to Ghana on Wednesday.
(Arul Louis can be reached at and followed on Twitter at @arulouis)
–IANS
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