. . World News – CA – U. . ONE. E.. . Is the first government to approve a Chinese coronavirus vaccine


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However, the announcement by the United Arab Emirates was met with silence by the Chinese vaccine manufacturer and raised further questions.

The United Arab Emirates issued the first state approval for a Chinese coronavirus vaccine on Wednesday. They cite preliminary data showing that it is 86 percent effective. This could bring Chinese vaccines one step closer to widespread use.

The announcement by the Emirates’ Ministry of Health and Prevention was the first official indicator of the potential of a Chinese vaccine to stop the pandemic. If results from other countries show similar results, then Chinese vaccines could provide a lifeline for developing countries that US vaccines cannot afford, which are likely to be more expensive and difficult to ship.

But Chinese officials and Sinopharm, the state manufacturer of the vaccine, were silent on Wednesday about the information in the Emirates. And scientists found that the announcement was missing data and other vital details.

The news that a Chinese vaccine is 86 percent effective and crosses the 50 percent threshold set by many governments strengthens China’s biomedical ambitions. However, it lags behind the performance of American drug makers Pfizer and Moderna, who previously said their vaccines are more than 90 percent effective at protecting against the coronavirus.

The Emirates, one of ten countries where Sinopharm is testing its two vaccines, said they reviewed an interim analysis of data from Sinopharm’s late-stage clinical trials that showed the vaccine was 100 percent effective in the disease Prevention from moderate and severe vaccines is cases of the disease. There were no serious safety concerns, it said.

“The announcement is a significant vote of confidence by the U. . ONE. E.. . The health authorities in relation to the safety and effectiveness of this vaccine, « the ministry said in a press release from the state-run Emirates news agency. The government did not say whether it conducted an independent analysis of the raw data.

The data from the Emirates is a good sign that Sinopharm’s vaccines are receiving full regulatory approval in China, which Sinopharm applied for prior to the completion of the final studies. The company is also conducting trials in Bahrain, Jordan, Peru, Argentina and elsewhere.

« I think it could hit the market in China very soon and there will be news for the next week or two, » said Tao Lina, vaccine expert in China and former immunologist at the Shanghai Center for Disease Control and Contraception.

The vaccine could also help bring China closer to fulfilling a promise made by China’s leader Xi Jinping to make vaccine a « global public good. ». ”

But even as the Emirates’ announcement raised hopes of the promise of Chinese vaccines, it pointed to a frustrating lack of clarity that has been following China’s coronavirus vaccine development for months.

Sinopharm would not endorse or comment on the Emirates news even hours after it was published. A company spokeswoman hung up when reached and then did not answer messages and calls.

The UAE government’s press release contained few other important details, such as the number of Covid-19 cases analyzed or the age of the volunteers, which made it unclear to the scientists how Sinopharm came to its conclusions.

« The devil is in the details, » said Beate Kampmann, director of the vaccine center at the London School for Hygiene and Tropical Medicine. « It is very difficult to judge this without seeing the number of cases. The main thing is that the test results must be published. ”

Jin Dongyan, a virologist at the University of Hong Kong, called the information in the Emirates disclosure « mediocre » and said more transparency was needed from the vaccine manufacturer.

« If they do everything secretly, like a black box, it won’t help, » said Professor Jin. “That would only create confusion and distrust and could be counterproductive. ”

The need for clarity about the safety and effectiveness of China’s vaccines became more urgent after Sinopharm announced that it had vaccinated around one million people prior to the completion of clinical trials. The campaign has alarmed scientists from overseas who claim it is exposing people to inappropriate risks.

Chinese officials have repeatedly assured the public that the country’s coronavirus vaccines are safe, giving few details. Last month, Sinopharm chairman Liu Jingzhen said that none of those who received the company’s vaccines had experienced any side effects. He said that “Few had mild symptoms. ”

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In October, Zheng Zhongwei, a senior health official, said the government had set up a « follow-up program » to follow up those vaccinated, although he did not provide details.

Sinovac Biotech, a Beijing-based private vaccine maker, has already started exporting its vaccines to countries like Indonesia and Brazil. Sinopharm, which has another late-stage vaccine, is preparing to ship 500 million doses worldwide, according to the state-run Science and Technology Daily.

It is unclear whether the Emirates will use the Chinese vaccine, which Sinopharm developed together with the Beijing Institute of Biological Products, for mass vaccination. The government approved the vaccine for emergency use back in September for frontline workers who are at risk of contracting Covid-19.

Some other countries where Sinopharm is conducting studies rely on Chinese vaccines to protect their populations. Morocco says it is preparing to vaccinate 80 percent of its adults, relying on a Sinopharm vaccine initially, although it would wait for China to approve the vaccine, according to Médias24, a Moroccan news website.

The Chinese vaccines also appeal to developing countries because they may be easier to distribute. According to Sinopharm, the vaccines only need to be cooled at temperatures of 2 to 8 degrees Celsius and can remain stable for up to three years. In contrast, Pfizer and Moderna vaccines, which are made from genetic materials that fall apart when thawed, require industrial freezers, which makes transport and storage more difficult.

Sinopharm’s vaccines are both made from killed or weakened coronaviruses, a technique that has been used in influenza vaccines and polio vaccines for decades, for example. For comparison, Moderna and Pfizer vaccines are developed using technology that has never been approved for broad use.

Another benefit of the inactivated vaccines Sinopharm is developing is that they tend to have fewer adverse effects after immunization, according to Florian Krammer, an immunologist at the Icahn School of Medicine on Mount Sinai in New York. He said more clarity about the studies in the Emirates would be appreciated, but expressed his confidence in the vaccine’s initial results.

« It would be great to see some of this data, » said Professor Krammer in an email. “But 86 percent is a respectable number, there is absolutely nothing wrong with that. I would take such a vaccine. ”

Serum Institute of India, Vaccine, Emergency Approval, India, Coronavirus, Pfizer, Drugs Controller General of India

World News – CA – U. . ONE. E.. . Is the first government to approve a Chinese coronavirus vaccine

Ref: https://www.nytimes.com

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