Scientists see downsides to top COVID-19 vaccines from Russia, China

By Allison Martell and Julie Steenhuysen

TORONTO/CHICAGO (Reuters) – High-profile COVID-19 vaccines developed in Russia and China share a potential shortcoming: They are based on a common cold virus that many people have been exposed to, potentially limiting their effectiveness, some experts say.

CanSino Biologics’ vaccine, approved for military use in China, is a modified form of adenovirus  type 5, or Ad5. The company is in talks to get emergency approval in several countries before completing large-scale trials, the Wall Street Journal reported last week.

A vaccine developed by Moscow’s Gamaleya Institute, approved in Russia earlier this month despite limited testing, is based on Ad5 and a second less common adenovirus.

“The Ad5 concerns me just because a lot of people have immunity,” said Anna Durbin, a vaccine researcher at Johns Hopkins University. “I’m not sure what their strategy is … maybe it won’t have 70% efficacy. It might have 40% efficacy, and that’s better than nothing, until something else comes along.”

Vaccines are seen as essential to ending the pandemic that has claimed over 845,000 lives worldwide. Gamaleya has said its two-virus approach will address Ad5 immunity issues.

Both developers have years of experience and approved Ebola vaccines based on Ad5. Neither CanSino nor Gamaleya responded to requests for comment.

Researchers have experimented with Ad5-based vaccines against a variety of infections for decades, but none are widely used. They employ harmless viruses as “vectors” to ferry genes from the target virus – in this case the novel coronavirus – into human cells, prompting an immune response to fight the actual virus.

But many people already have antibodies against Ad5, which could cause the immune system to attack the vector instead of responding to the coronavirus, making these vaccines less effective.

Several researchers have chosen alternative adenoviruses or delivery mechanisms. Oxford University and AstraZeneca based their COVID-19 vaccine on a chimpanzee adenovirus, avoiding the Ad5 issue. Johnson & Johnson’s candidate uses Ad26, a comparatively rare strain.

Dr. Zhou Xing, from Canada’s McMaster University, worked with CanSino on its first Ad5-based vaccine, for tuberculosis, in 2011. His team is developing an inhaled Ad5 COVID-19 vaccine, theorizing it could circumvent pre-existing immunity issues.

“The Oxford vaccine candidate has quite an advantage” over the injected CanSino vaccine, he said.

Xing also worries that high doses of the Ad5 vector in the CanSino vaccine could induce fever, fueling vaccine skepticism.

“I think they will get good immunity in people that don’t have antibodies to the vaccine, but a lot of people do,” said Dr. Hildegund Ertl, director of the Wistar Institute Vaccine Center in Philadelphia.

In China and the United States, about 40% of people have high levels of antibodies from prior Ad5 exposure. In Africa, it could be as high as 80%, experts said.

HIV RISK

Some scientists also worry an Ad5-based vaccine could increase chances of contracting HIV.

In a 2004 trial of a Merck & Co Ad5-based HIV vaccine, people with pre-existing immunity became more, not less, susceptible to the virus that causes AIDS.

Researchers, including top U.S. infectious diseases expert Dr. Anthony Fauci, in a 2015 paper, said the side effect was likely unique to HIV vaccines. But they cautioned that HIV incidence should be monitored during and after trials of all Ad5-based vaccines in at-risk populations.

“I would be worried about the use of those vaccines in any country or any population that was at risk of HIV, and I put our country as one of them,” said Dr. Larry Corey, co-leader of the U.S. Coronavirus Vaccine Prevention Network, who was a lead researcher on the Merck trial.

Gamaleya’s vaccine will be administered in two doses: The first based on Ad26, similar to J&J’s candidate, and the second on Ad5.

Alexander Gintsburg, Gamaleya’s director, has said the two-vector approach addresses the immunity issue. Ertl said it might work well enough in individuals who have been exposed to one of the two adenoviruses.

Many experts expressed skepticism about the Russian vaccine after the government declared its intention to give it to high-risk groups in October without data from large pivotal trials.

“Demonstrating safety and efficacy of a vaccine is very important,” said Dr. Dan Barouch, a Harvard vaccine researcher who helped design J&J’s COVID-19 vaccine. Often, he noted, large-scale trials “do not give the result that is expected or required.”

(Additional reporting by Christine Soares in New York, Kate Kelland in London, Polina Ivanova in Moscow and Roxanne Liu in Beijing; Editing by Caroline Humer and Bill Berkrot)

Rogue Chinese scientist made ‘foolish’ choice in gene-edited babies

FILE PHOTO: Scientist He Jiankui speaks at his company Direct Genomics in Shenzhen, Guangdong province, China July 18, 2017. Picture taken July 18, 2017. REUTERS/Stringer

By Kate Kelland

LONDON (Reuters) – A rogue Chinese scientist who caused outrage last year when he said he had created the world’s first “gene-edited” babies in an attempt to protect them from HIV may also have put them at risk with a “foolish” choice of gene, experts said on Monday.

He Jiankui, then an associate professor at the Southern University of Science and Technology in Shenzhen, China, sparked an international scientific and ethical row when he said he had used a technology known as CRISPR-Cas9 to alter the embryonic genes of twin girls born in November 2018.

He said he had targeted a gene known as CCR5 and edited it in a way he believed would protect the girls from infection with HIV, the virus that causes AIDS.

But in a study published in the journal Nature Medicine on Monday, scientists found that people who have two copies of a so-called “Delta 32” mutation of CCR5 – which protects against HIV infection in some people – also have a significantly higher risk of premature death.

The researchers, Xinzhu Wei and Rasmus Nielsen of the University of California, Berkeley, said their findings showed the unintended consequences of introducing mutations in humans.

Robin Lovell-Badge, a leading geneticist and the organizer of a conference where He Jiankui made his revelation, said the results showed the Chinese scientist “was foolish to choose CCR5 to mutate in his attempts at germline genome editing”.

“We simply do not yet know enough about the gene,” said Lovell-Badge, a professor and gene expert at Britain’s Francis Crick Institute.

He Jiankui could not immediately be reached for comment.

Other specialists agreed the findings underline a need for extreme caution when considering possible human applications of gene editing technologies.

“This study should act as a stark warning that manipulation of the human genome with the aim of reducing susceptibility to specific diseases is not without considerable risk,” said Andrew Freedman, an infectious diseases expert at Cardiff University.

The Berkeley team’s study analyzed genotype and death register details from more than 400,000 people registered at the UK Biobank – a database of health and genetic information.

They found that people who have two copies of the Delta 32 mutation are about 20% less likely to reach age 76 compared with people who have one or no copies.

Chinese authorities immediately denounced He when he made his claim last year and issued a temporary halt to research activities involving the editing of human genes. He was fired after a subsequent Chinese health commission investigation found he had “deliberately evaded oversight”.

(Reporting by Kate Kelland; Editing by Andrew Cawthorne)

China orders halt to gene-editing after outcry over babies

Scientist He Jiankui attends the International Summit on Human Genome Editing at the University of Hong Kong in Hong Kong, China November 28, 2018. REUTERS/Stringer

By Alexandra Harney

SHANGHAI (Reuters) – The Chinese government on Thursday ordered a temporary halt to research activities for people involved in the editing of human genes after a Chinese scientist said he had edited the genes of twin babies.

Scientist He Jiankui said this week that he used a gene-editing technology known as CRISPR-Cas9 to alter the embryonic genes of the twin girls born this month.

He’s announcement, which has not been verified, sparked an international outcry about the ethics and safety of such research.

“The nature of this incident is extremely nasty, and relevant bodies have been ordered to temporarily halt the scientific research activities of relevant personnel,” the state news agency Xinhua said, citing the health ministry, science and technology ministry and China Association for Science and Technology.

The organizers of a conference where He claimed to have edited the genes also condemned the work on Thursday, calling it “deeply disturbing” and “irresponsible”.

“Even if the modifications are verified, the procedure was irresponsible and failed to conform with international norms,” the organizing committee of the Second International Summit on Human Genome Editing, being held in Hong Kong this week, said in a statement.

The committee called for an independent assessment of He’s claims.

He said gene editing would help protect the girls from infection with HIV, the virus that causes AIDS.

Chinese scientists have also condemned the work and the Southern University of Science and Technology, where He is on leave from his position as an associate professor, has announced an investigation.

The Guangdong province Health Commission said on its website on Wednesday it and Shenzhen city had set up a team to investigate the case.

He’s filing to a Chinese clinical trials database indicates that a hospital did an ethical review of the project, but the hospital involved denied that its ethics review committee ever met to discuss the work.

He said after his presentation on Wednesday he was proud of what he had done.

The presidents of the U.S. National Academy of Sciences (NAS) and the U.S. National Academy of Medicine (NAM) also expressed concern about He’s work.

“The events in Hong Kong this week clearly demonstrate the need for us to develop more specific standards and principles that can be agreed upon by the international scientific community,” NAS president Marcia McNutt and NAM president Victor Dzau said in a statement.

(This story fixes typo in first paragraph)

(Reporting By Alexandra Harney; Additional reporting by Ben Blanchard in Beijing; Editing by Paul Tait, Robert Birsel)

U.S. suspends aid to Kenyan health ministry over corruption concerns

FILE PHOTO: A riot policeman stands guard as doctors chant slogans after their case to demand fulfilment of a 2013 agreement between their union and the government that would raise their pay and improve working conditions, was heard at the employment and labour relations courts in Nairobi, Kenya, February 13, 2017. REUTERS/Thomas Mukoya/File Photo

By Katharine Houreld

NAIROBI (Reuters) – The U.S. government has suspended $21 million in direct aid to Kenya’s Ministry of Health amid concern over corruption, the embassy said on Tuesday, giving emphasis to an issue that is a growing liability for the government before August elections.

Support for HIV drugs and other health programs outside the ministry would continue, the embassy said, adding that the United States invests more than $650 million on health in Kenya annually.

“We took this step because of ongoing concern about reports of corruption and weak accounting procedures at the Ministry,” the statement from the embassy said. “We are working with the Ministry on ways to improve accounting and internal controls.”

The announcement adds weight to a rising number of scandals plaguing the government of President Uhuru Kenyatta, who is seeking a second and final five-year term in presidential, parliamentary and local elections on Aug. 8.

The so-called Afya House scandal, named after the building housing the Ministry of Health, was based on an audit report leaked to Kenyan media in October.

The audit showed the ministry could not account for 5 billion Kenyan shillings ($49 million) and funds meant for free maternity care had been diverted, newspapers reported.

Officials at Kenya’s anti-corruption commission did not return calls seeking comment on Tuesday, but the ministry of health issued a statement.

“The ministry has been raising matters raised in the internal audit investigations following the Quality Assurance audit by the National Treasury,” the statement said.

“Other autonomous institutions … are undertaking independent investigations.”

Last year, Kenya’s anti-graft chief told Reuters that a third of its state budget – the equivalent of about $6 billion – was lost to corruption every year.

The government disputed the figure, blaming poor paperwork. In October, Kenyatta infuriated voters by telling them he could not tackle corruption because his “hands were tied”. He criticized the judiciary and other agencies for not doing more about the problem.

Kenyan doctors and nurses say the corruption means that hospitals are often left without basic equipment, from drugs to gloves. Kenyan doctors in public hospitals went on strike from December to March, demanding a pay increase and improved working conditions.

(Editing by Larry King)

More than 18 million on AIDS treatment a million more than 2015

A nurse (L) hands out a red ribbon to a woman, to mark World Aids Day, at the entrance of Emilio Ribas Hospital, in Sao Paulo

By Kate Kelland

LONDON, Nov 21 – More than 18 million people now have access to life-saving AIDS treatment, 1.2 million more than at the end of last year, the United Nations said on Monday.

In a report on the AIDS pandemic, which has infected 78 million people and killed 35 million since it began in the 1980s, UNAIDS said the consistently strong scale-up of treatment has seen annual AIDS-related deaths drop by 45 percent to 1.1 million in 2015 from a peak of about 2 million in 2005.

But, as more HIV-positive people live longer, the challenges of caring for them as they get older, of preventing the virus spreading and of reducing new infections are tough, UNAIDS said, even though drugs can reduce virus levels in a patient’s blood to near zero and significantly reduce the risk of passing it on.

“The progress we have made is remarkable, particularly around treatment, but it is also incredibly fragile,” UNAIDS’ executive director Michel Sidibe said as the report was published.

With detailed data showing some of the many complexities of the HIV epidemic, the report found that people are particularly vulnerable to HIV at certain points in their lives.

It called for “life-cycle” approach to offer help and prevention measures for everyone at every stage of life.

As people with HIV grow older, they are at risk of developing long-term side-effects from HIV treatment, developing drug resistance and requiring treatment for other illnesses such as tuberculosis and hepatitis C.

The report also cited data from South Africa showing that young women who become infected with HIV often catch the virus from older men. It said prevention is vital to ending the epidemic in young women and the cycle of HIV infection needs to be broken.

“Young women are facing a triple threat,” said Sidibe. “They are at high risk of HIV infection, have low rates of HIV testing, and have poor adherence to treatment.”

The report, saying the number of people with HIV getting life-saving drugs was 18.2 million, also showed that the rapid progress in getting AIDS drugs to those who need them is having a significant life-extending impact.

In 2015, there were 5.8 million people aged over 50 living with HIV – more than ever before.

UNAIDS said that if treatment targets are reached – the U.N. is aiming to have 30 million HIV positive people on treatment by 2020 – that number will soar.

(Editing by Louise Ireland)

Cuba Eliminates Mother-To-Child HIV Transmission

The World Health Organization (WHO) has announced that Cuba is the first country in the world to eliminate the transmission of HIV from mother to child.  The country is also the first to eliminate the transfer of syphilis.

WHO officials say that the discovery means an end to the AIDS epidemic is possible and they expect more nations to seek to reach the status where transmission is eliminated in their country.

“Eliminating transmission of a virus is one of the greatest public health achievements possible,” Dr. Margaret Chan, the WHO director-general, said in a Tuesday press release. “This is a major victory in our long fight against HIV and sexually transmitted infections, and an important step towards having an AIDS-free generation.”

The WHO defines elimination as reduction to a level that it no longer constitutes a public health problem.  In 2013, only two babies were born in Cuba with HIV and only five with syphilis.

The WHO says that without treatment, a woman has up to a 45% risk of transmitting the virus to her child.  The WHO is currently undergoing a worldwide program to eliminate transmission but are struggling to meet their goal of only 40,000 infections in 2015.  The last reported total was 240,000 in 2013, a decrease of 160,000 from 2009.

Nearly 2 in 3 Illinois Abortion Clinic Had No Health Inspections for Years

A new report shows that some of Illinois’ abortion clinics had not had an inspection from the state’s Department of Public Health in almost a decade.

The report from Illinois Right To Life says that 63 percent of the abortion clinics in the state had not received a health or sanitary inspection in three and a half years.

“The failure of the Department of Public Health to conduct regular health and sanitary inspections leaves women open to the prospect of unsterile surgical tools, dirty operating rooms, incomplete medical attention, infections, and possibly more deaths,” the group says.

The group discovered there is no inspection policy for abortion clinics regarding cleanliness or sanitation.

“It’s quite scary,” Emily Zender, the group’s executive director, says in the report. “While news reports warn of MRSA, urge flu vaccination, and praise hospital Ebola training, abortion providers are allowed to perform invasive surgical procedures in unsanitary conditions.”

The state’s five Planned Parenthood locations that perform abortions are not licensed and the state has not inspected them for sanitary conditions since 2000.

The state could not provide documentation that women who underwent abortions in the unsanitary clinics were warned about possible exposure to HIV or other infections and diseases because of dirty equipment.

New Aggressive HIV Strain Discovered

A new strain of HIV that develops into AIDS significantly faster than other types has been discovered in West Africa.

Researchers say the new A3/02 strain of the virus can develop into AIDS within five years of the first infection making it one of the fastest time periods from the initial infection.  The virus is called a “recombinant” virus that is made from the union of two previously known viral strains.

“Recombinants seem to be more vigorous and more aggressive than the strains from which they developed,” Angelica Palm of Lund University told Fox News.

The author of the study said that it’s likely multiple recombinant viruses are circulating through populations that researchers have yet to discover.

“HIV is an extremely dynamic and variable virus. New subtypes and recombinant forms of HIV-1 have been introduced to our part of the world, and it is highly likely that there are a large number of circulating recombinants of which we know little or nothing,” Dr. Patrik Medstran said.