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News at a glance: AI rules for Europe, vaccines for Africa, and a union for NIH early-career researchers



HEALTH EQUITY

A billion-dollar boost for vaccinemaking in Africa

Gavi, the Vaccine Alliance, has committed up to $1 billion to bolster Africa’s ability to sustainably produce its own doses of lifesaving vaccines. Manufacturers based in Africa produce only 1% of the vaccine doses used on the continent. Last week, Gavi announced that with money left over from the COVID-19 Vaccines Global Access Facility—an effort to provide an equitable distribution of COVID-19 vaccines—it would create the African Vaccine Manufacturing Accelerator (AVMA) to focus on preventing 11 priority infectious diseases. As an incentive to begin making the doses, AVMA will give a manufacturer $10 million to $25 million for each vaccine that the World Health Organization determines meets international quality standards. If Gavi and its partner, UNICEF, agree to buy the vaccine, AVMA will “top up” the price paid by as much as 50 cents extra per dose as an “accelerator payment.” Its goal is to help at least four African manufacturers supply a total of more than 800 million doses over a decade.

REGULATION

EU agrees to landmark AI rules

After marathon negotiations, the European Union’s three main governing bodies last week approved a comprehensive new law governing the development and use of artificial intelligence (AI) systems across the bloc. The world’s first enacted legislation of its kind, the measure bans certain applications, such as the untargeted scraping of facial images from the internet and closed-circuit TV footage to create databases. It imposes the most restrictions on classes of AI categorized as posing a high risk of harm to health, safety, the environment, or fundamental rights. Companies that don’t comply could be fined up to €35 million or 7% of global adjusted revenue. The regulation exempts systems used for defense, research, and innovation. To help smaller European companies stay relevant in the global race to develop AI, the law leaves it up to national authorities to set up “regulatory sandboxes” that would provide controlled environments for developing and training AI systems.

LABOR RELATIONS

NIH workers vote to unionize

NIH headquarters
Fellows at the National Institutes of Health protested for better pay and working conditions outside the agency’s main administration building in June.MELISSA LYTTLE

Early-career researchers at the U.S. National Institutes of Health (NIH) last week voted 98% in favor of forming a union—the first of its kind at a federal research agency, joining a growing wave of such unionization efforts at universities across the country. The bargaining unit, called NIH Fellows United, is set to represent more than 5000 nonpermanent researchers, including graduate students, postdocs, and research fellows, who work at NIH research facilities. Under federal rules, workers won’t be permitted to engage in strike activity. But organizers hope the union will push for better pay and working conditions.

BIOMEDICINE

U.S. OKs gene editing for sickle cell

The U.S. Food and Drug Administration (FDA) has approved for the first time a medical treatment that uses the gene-editing tool CRISPR. The therapy offers a genetic fix for sickle cell disease, which is caused by defects in the oxygen-carrying protein hemoglobin. The product, Casgevy, developed by Vertex Pharmaceuticals and CRISPR Therapeutics, uses CRISPR to turn on a gene for the fetal form of hemoglobin in a lab-grown population of a patient’s harvested blood stem cells. The cells are then returned to the body. When FDA announced its decision last week, it also approved another sickle cell therapy— Lyfgenia, from maker bluebird bio—that adds a gene for adult hemoglobin to similar stem cells. The U.S. approval comes soon after the United Kingdom became the first country to approve a CRISPR treatment for sickle cell, on 15 November. For these potentially one-time treatments, Casgevy is priced at $2.2 million, Lyfgenia at $3.1 million.

INFECTIOUS DISEASES

HIV vaccine trial ends in failure

In an all too familiar disappointment, the only remaining HIV vaccine efficacy trial has been stopped early after poor results. Following failed trials of other HIV vaccines going back more than 2 decades, the PrEPVacc study began in 2020 and enrolled more than 1500 volunteers in South Africa, Tanzania, and Uganda. They received one of two combinations of up to four vaccines that present HIV proteins to the immune system in different ways. Study leaders hoped to report results next year. But an independent data monitoring committee notified them last month that results to date indicated no chance that either strategy being tested was protective. At an international AIDS conference in Zimbabwe on 4 December, PrEPVacc’s leaders publicly announced the decision to stop vaccinating participants. As part of the trial, all of them also have received anti-HIV pills, known as pre-exposure prophylaxis (PrEP). The study will continue to provide PrEP and assess its impact on infection rates.

TECHNOLOGY TRANSFER

Biden wants NIH to eye drug costs

President Joe Biden’s administration last week proposed strengthening the leverage of U.S. federal agencies to force those who hold patents resulting from taxpayer-funded research to more broadly license them. Biden’s move comes as he faces political pressure to help lower the high price of key medicines, such as the prostate cancer drug Xtandi. Under a 1980 law, owners of such patents may exclusively license them to companies; if public access is prevented, the government can force the patent owner to issue more licenses. Biden’s proposal would clarify that the National Institutes of Health (NIH) can deem a drug’s high price a barrier to public access. NIH has never exercised its “march-in rights,” despite requests from advocates. Drug companies and academic institutions say it would dissuade industry from commercializing NIH-funded research. The Department of Commerce is accepting comments on the proposal until 6 February.

#METOO

AAAS strips harasser of honor

AAAS said this week it has revoked the honorary fellowship of molecular biologist David Gilbert after his former institution found he engaged in severe, pervasive sexual harassment. The society’s 8900 active fellows are recognized for distinguished achievements and normally elected for life. In 2018, AAAS began to allow removal of the title for documented scientific misconduct, including harassment. Science, which AAAS publishes, reported in April that Gilbert’s former employer, Florida State University, made the determination of harassment in 2020; the next year, he moved to the San Diego Biomedical Research Institute, which Florida State did not inform about its finding. In San Diego, one trainee reported being harassed, but a probe by the institution found no “unlawful harassment.”

POLICY

Macron names science advisers

French President Emmanuel Macron last week established the country’s first multidisciplinary scientific advisory council to help him “fully put science at the heart” of political decisions. (Other, specialized panels have advised the government on climate change and the pandemic.) Comprising 12 French scientists including two Nobel laureates and five women, the council will meet privately with Macron each quarter; its remit includes proposing new projects to build. Unlike some other countries, France does not have the position of chief scientific adviser.

CONSERVATION

Australia buys water for ecosystem

Australia’s government on 7 December enacted a law allowing it to buy more water from farmers to improve the ecology of the country’s largest river system, the Murray-Darling Basin. Scientists have documented that low water flows have caused chronic harm, including algal blooms and fish kills. The law guarantees the basin a quantity of water promised under a 2012 policy. Under a previous policy, the government capped the amount of water rights it bought, which hindered the ecosystem’s recovery.

Source : Science

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