A Chinese scientist's attempt to produce the world's first gene-edited babies who are immune to HIV has sparked heated controversy among those in academia and the public.

In an online video posted on Monday, He Jiankui, a biological researcher, announced that a pair of twin baby girls, Lulu and Nana, were born healthy a few weeks ago through in-vitro fertilization with genetic editing technology that can prevent them from being infected with HIV.

"The mother started her pregnancy by regular IVF with one difference: right after sending her husband's sperm into her eggs, we also sent in a little bit of protein and instruction for a gene surgery," He, from the Southern University of Science and Technology in Shenzhen, Guangdong province, said in the video. "Lulu and Nana were just a single cell when the surgery removed the doorway through which HIV enters to infect people."

He, who was believed to be in Hong Kong on Monday to attend the Second International Summit on Human Genome Editing, a three-day conference due to open on Tuesday, could not be reached for comment. But his announcement sparked heated controversy among regulators and academics concerning medical ethics and effectiveness.

The Shenzhen Health and Family Planning Commission said on Monday evening that it had not received any ethical assessment application for the study, which is a prerequisite for such experiments.

A report by The Associated Press on Monday said He sought and received approval for his project from the ethics committee of the Shenzhen Harmonicare Women's and Children's Hospital, and an approval document from the hospital circulated online on Monday.

However, the Shenzhen commission said the hospital's ethics committee was invalid, as the hospital did not register as required with the commission about the establishment of such a committee.

The commission started an ethics investigation into the issue and will release the result to the public, it said. The hospital would not comment on Monday.

The Southern University of Science and Technology said in a statement on Monday that the university was not aware of the research, as He did not report it to the school.

The university said the academic council of its Biology Department, where He works as an associate professor, believes that the research has seriously violated academic ethics and rules, and the university would immediately set up an independent investigation team on the matter.

A regulation released in 2016 by the previous National Health and Family Planning Commission — the current National Health Commission — requires health institutions to establish ethical committees for ethical inspection over biological or medical research that involves humans before they get approval, while the national health authority is responsible for researching into major ethics issues concerning such research and providing guidance to local health authorities.

The National Health Commission did not reply to questions sent by China Daily on Monday.

Bai Hua, head of Baihualin, a nongovernmental organization that promotes the interests of people with HIV/AIDS, told China Daily on Monday that the parents of the two babies are people with HIV.

He Jiankui talked to Bai in April last year, hoping to find people with HIV for the research, Bai said, adding he spread the news to such people he knew, and about 200 showed interests.

"Of the group infected with HIV, many are with special conditions, such as they are unable to naturally conceive, but the reality is that they cannot get babies through IVF in hospitals," he said. "Many of them think the research gives them a chance to have babies without the risk of getting HIV as they do."

The fear of opening "Pandora's Box"

On Monday, more than 120 scholars from prestigious universities and institutes from China and abroad, such as Tsinghua University and the Massachusetts Institute of Technology, strongly condemned the research in a signed statement, saying the "research" lacks effective ethics inspection, and it amounts to human experimentation, which is "crazy".

In the statement, published on Sina Weibo, the Chinese equivalent of Twitter, the scientists said any attempt to make changes to human embryos with genetic editing and give birth to such babies entails high risk, due to inaccuracies in existing genetic editing technologies.

"Scientists all over the world dare not make such attempts due to the huge risks and more importantly, ethics," the statement said.

Once a living human is produced in this way, his or her genes will be mixed with human genes of others, and no one can foresee the consequences, it said.

"The government must make quick legislative moves to strictly supervise such research," it said. "The Pandora's Box has been opened, and we may still have a chance of closing it before it is too late."

Wu Zunyou, chief epidemiologist at the Chinese Center for Disease Control and Prevention, said he was astounded to hear of the birth of twins with edited genes.

"Genetic editing technology is far from mature and could have unforeseen consequences on the subjects," he told China Daily. "It is improper to do such research on humans."

Right now there are some researchers trying to use genetic editing technology to treat people infected with HIV, so the virus will not duplicate and transmit to others, he said.

"But the research is still confined to labs," he said. "Animal experiments should be done to assess both gains and risks for the subjects, before the possibility of application to humans."

Some scientists attending the summit in Hong Kong on Tuesday think it could introduce serious problems to the human immune system, while others think people should not be overly concerned or frightened as it would not affect the core genome, and families of HIV patients could benefit from it, if the test is true and successful.

Tsui Lap-chee, president of the Academy of Sciences of Hong Kong, said a lot of issues may occur in gene editing. If one gene is edited, it will affect others that interact with it. And the whole genome, a collection of genes, may also be affected.

"As genes play a role in the immune system, if you take away a certain gene, maybe the immune system is compromised," explained Robin Lovell-Badge, group leader and head of the Division of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute.

Though people are immune to certain diseases, saying they have the ability to resist the AIDS virus, there are perhaps other diseases that people are more susceptible to, Lovell-Badge said.

However, Lovell-Badge said, "Gene editing is not something to be afraid of", adding that he doesn't think what He has done will affect the core human genome. As for side effects, they may not be very serious, as there are millions of people having the exact same mutation living healthily.

"Gene editing is something we need to think deeply about what should be committed to and what should not," he said. "How to regulate the work really matters."

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