Covid-19 vaccine was tested on Myanmar military personnel without their consent—sources

Members of Myanmar’s military were given doses of a Covid-19 vaccine imported from India without being informed that it had not yet been approved, according to army sources.

The military’s secret vaccination program, which used the Covaxin vaccine produced by Indian pharmaceutical company Bharat Biotech, began in January and continued for three months, the sources told Myanmar Now.

Those who received the vaccine were not told that it was still in the third phase of clinical trials at the time, according to several people who had taken part in the program.

“They said they were going to vaccinate us and then check our immunity two weeks after the jab to see if it had gone up. So you could say it was a test,” said one officer who was among the first batch of test subjects.

The officer, who was stationed at a military hospital in Yangon’s Mingaladon Township, told Myanmar Now that 15 soldiers, including himself, had blood drawn from them three times after each of the two shots they received.

He said the program was later expanded to include more military personnel after the results from the first 15 subjects were examined.

“I thought they were taking blood from everyone. But later we learned it was just us. We even joked that we were being used as lab rats,” he said. 

“It’s infuriating, but there’s nothing you can do about it, because this is the army.”

A healthcare worker attached to a military hospital receives an injection of the Covaxin vaccine in late January (Facebook) 

Unwitting volunteers

Another person who was required to take part in the program as a test subject said that it was carried out under orders from senior officers.

“They wanted a study population to serve as a record of people who were given the shots, maybe 100,000 people or so,” said a doctor from another military hospital in Yangon. “To be honest, I think it’s sad that we were used as human guinea pigs this way.”

The doctor, who asked not to be identified, said that two teams were involved in collecting data from those who had received the vaccine.

“There was a group of people keeping track of how our bodies reacted to the vaccine—how many people developed a fever, how many became nauseated—and another that tested how much the amount of antibodies in our blood increased after the vaccination,” he said.

The wife of a navy officer told Myanmar Now that her husband, who was given the first shot in mid-February and the second a month later, eventually learned that the vaccine he received was Covaxin, and not the approved Covishield vaccine, also produced in India, that was used in the national vaccination program launched by Myanmar’s civilian government days before it was ousted from power on February 1.

She added that while her husband was able to obtain this information because of his rank, it was unlikely that ordinary soldiers included in the military’s vaccination program were aware of this fact.

Indian media reported that the Covaxin vaccine had received emergency-use approval in 16 countries by the end of June (EPA/EFE)

Bharat Biotech began Phase 3 trials for Covaxin last November, but by early January, it still hadn’t made much progress due to a lack of volunteers willing to try the vaccine. 

The company, which has denied conducting any clinical trials outside of India, told Myanmar Now by email that it sent 55 vials of the vaccine to Myanmar in January, but added that this was standard practice when dealing with prospective buyers.

However, on February 11, another 200,000 doses of Covaxin were shipped to Myanmar as part of the Indian government’s Vaccine Maitri diplomacy program, under which 1.5m doses of Covishield had already been sent on January 22.

On January 27, India’s online Mint news outlet reported that Bharat Biotech was seeking approval from the governments of Myanmar and Bangladesh to test Covaxin in the two countries.

An official from the Indian Council for Medical Research (ICMR), Bharat Biotech’s partner in producing the vaccine, is cited in the article as saying that such trials are a normal part of the procedure followed by countries looking to procure vaccines. The article also noted, however, that Bharat Biotech declined to make any comment on the subject of foreign trials.

Unlike Covishield, which is manufactured by the Serum Institute of India under license to the multinational pharmaceutical and biotechnology company AstraZeneca, Covaxin was developed in India. By late June, it had received emergency-use approval in 16 countries, according to local media reports

The World Health Organization (WHO), which received a request for inclusion of Covaxin on its Emergency Use Listing in early July, has yet to complete its review of the submitted data. 

Trial denial

Most government officials, including those from the former civilian government, deny having any knowledge of the military’s vaccine trial program.

Dr. Win Myat Aye, who headed the Ministry of Social Welfare, Relief and Resettlement under the ousted National League for Democracy-led government, and Dr. Zaw Wai Soe, who played a key role in that government’s Covid-19 response efforts, and who now serves as the shadow National Unity Government’s health minister, both said they were unaware of any Covaxin-related program that might have existed prior to the coup.   

At the end of January, shortly before the military takeover, Health Ministry spokesperson Dr. Khin Khin Gyi told local media outlet Eleven News that the government had no plans to test Covaxin in Myanmar.

In an interview with Myanmar Now on July 15, Dr. Htay Htay Tin, the deputy director of the National Health Laboratory and another leading figure in the effort to contain Covid-19, also said that there were no Covaxin trials conducted in Myanmar.

Less than a week later, Dr. Khin Zaw, the director of the Food and Drug Administration, said that civilians were given Covaxin shots in April.

“We’ve already given Covaxin vaccines in Myanmar. We gave all of the donated vaccines to civilians,” he told Myanmar Now on July 21, adding that the vaccines had been approved by the FDA for use, not for trial.

He added that the Public Health Department may have conducted some trials using data collected from those who received the vaccine, but he asserted that it had already been proven to be safe and effective by the time it was administered. 

Dr. Than Naing Soe, one of the directors of the Public Health Department, said that the department did not conduct Covaxin trials or approve research on the vaccine, although there had been some discussion about it.

“We refused to do the trials here. We don’t want our people to suffer just because another country wants to test their vaccine,” said Dr. Than Naing Soe, who is also a spokesperson for the Health Ministry under the current regime.

‘Approve whatever is available’

While the junta has not admitted to carrying out clinical trials on military personnel, senior figures in the regime have made no secret of their willingness to use vaccines that have not been approved by the WHO to combat Covid-19.

In February, the coup leader, Senior General Min Aung Hlaing, mentioned Covaxin as one of the vaccines the regime planned to buy, alongside others from China and Russia. 

In an interview with China’s state-run Xinhua news agency in April, the military council’s deputy information minister, General Zaw Min Tun, also counted Covaxin among the vaccines to be used in Myanmar.

As early as June, some companies were claiming that they had already received permission from the FDA to import Covaxin. On June 23, a local pharmaceutical company called SML announced on Facebook that it was accepting preorders for the vaccine.

Dr. Khin Zaw, the FDA director, said that SML was given the green light because it had submitted its request along with Bharat Biotech’s approval.

“If we were to turn down everything that was still pending approval from the WHO, we wouldn’t be able to approve most of the medicine here. The WHO-approved vaccines are almost impossible to get here at the moment, so we decided to approve whatever was available,” he said.

Since the third wave of the pandemic began in late June, the junta’s health authorities have been administering the Chinese vaccines Sinopharm and Sinovac to people over 65 years of age. These vaccines offer 51-79% protection from Covid-19.

The Chinese government donated 2.5 million doses of the Sinopharm vaccine to Myanmar and the regime has purchased 2 million doses of Sinovac.

A shipment of Covid-19 vaccines from China arrives in Yangon on August 8 (Chinese Embassy in Myanmar/ Facebook)

Those familiar with the Covaxin trial program say that the Indian vaccine has proven to be largely ineffective in preventing infection.

The wife of the navy officer said that almost everyone in her husband’s unit has contracted the disease despite being vaccinated with Covaxin.  

The officer from the Mingaladon military hospital said that two-thirds of those who took part in the Covaxin trials became infected soon after the third wave started. Despite being vaccinated, many developed symptoms of Covid-19, he said.

“First I came down with a fever, and then I lost my sense of smell. After that, I experienced nausea and stopped eating,” he said, describing common early signs of infection.

“Me, I’m not even going to test myself for Covid-19. I’ve been treating Covid-19 patients in my ward, so I’m pretty certain I already have it,” he added.

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