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BioWorld - Thursday, April 9, 2026
Home » Topics » Regulatory » WHO

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U.S. flag and White House podium

Is U.S. COVID-19 booster ‘judgment call’ the right call?

Aug. 19, 2021
By Mari Serebrov
The Biden administration’s rollout of a COVID-19 booster plan before the FDA has even approved a booster admittedly is a “judgment call,” U.S. health officials acknowledged Aug. 18. But rather than a judgment call, “the introduction of booster doses should be evidence-driven and targeted to the population groups in greatest need,” the World Health Organization advised in an interim statement issued a week before the White House COVID-19 Response Team’s announcement.
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Vial of Soberana-02 COVID-19 vaccine

Cuban COVID-19 vaccine surpasses WHO's minimum threshold

July 28, 2021
By Sergio Held
Interim data for Soberana-02, a Cuban COVID-19 conjugate vaccine, surpassed the threshold set by the WHO, according to the Finlay Institute of Vaccines (IFV) in Havana that developed it, although the results have not been peer reviewed.
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WHO setting up global framework to guide genome editing research

July 13, 2021
By Nuala Moran
LONDON – The World Health Organization (WHO) is to set up a channel for confidential reporting of illegal, unregistered, unethical or unsafe human genome editing research, as part of a new governance framework it is proposing to develop.
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WHO setting up global framework to guide genome editing research

July 12, 2021
By Nuala Moran
LONDON – The World Health Organization (WHO) is to set up a channel for confidential reporting of illegal, unregistered, unethical or unsafe human genome editing research, as part of a new governance framework it is proposing to develop.
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WHO recommends DNA testing for human papillomavirus

July 9, 2021
By Mark McCarty
The World Health Organization (WHO) reported a new set of guidelines regarding screening and treatment of cervical cancer, endorsing DNA testing for human papillomavirus (HPV) as the recommended test method.
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AI microchip illustration

WHO paper on AI lacking in specifics regarding transparency

July 1, 2021
By Mark McCarty
The World Health Organization’s (WHO) guidance for ethics and governance for artificial intelligence (AI) in health discusses several issues regarding regulation, including the question of transparency for the algorithm’s source code. The WHO paper is not prescriptive on this and several other issues, however, raising the prospect that regulatory entities will not be discouraged from adopting policies that run afoul of intellectual property concerns and thus impede advances in AI.
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WHO looks to advance global response to AIDS, TB, malaria

June 30, 2021
By Mari Serebrov
The World Health Organization (WHO) and the Global Fund to Fight AIDS, Tuberculosis and Malaria signed a cooperation and financing agreement to implement 10 initiatives in 2021 through 2023 aimed at addressing persistent challenges impeding global progress against the three diseases and protecting hard-won gains from new pandemics like COVID-19.
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International regulators call for voluntary disclosure of all trial data

May 10, 2021
By Mari Serebrov
Biopharma companies need to provide unredacted access to both positive and negative clinical data for all new drugs and vaccines, whether the drugs have been rejected, authorized for emergency use, or granted full or conditional approval, according to the World Health Organization (WHO) and international regulators. “The COVID-19 pandemic has brought into sharp focus the need for improved transparency of medical research,” said EMA Executive Director Emer Cooke, who also chairs the International Coalition of Medicines Regulatory Authorities (ICMRA).
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COVID-19 mRNA vaccine vials, syringe

With COVID-19 deaths on the rise, countries scramble for vaccines

April 20, 2021
By Mari Serebrov
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
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COVID-19 mRNA vaccine vials, syringe

With COVID-19 deaths on the rise, countries scramble for vaccines

April 19, 2021
By Mari Serebrov
As COVID-19 deaths across the globe top 3 million, with more than 1 million in Europe alone, the global demand is increasing for mRNA vaccines, even as sponsors of adenovirus vaccines push back against ongoing safety concerns. Last week, the World Health Organization’s (WHO) Regional Office for Europe reported that the confirmed COVID-19 death toll for the region had surpassed 1 million, with 1.6 million new cases being reported every week. More than 171 million doses of COVID-19 vaccines have been administered in the region, translating to nearly 13% of the European population receiving one dose and close to 6% completing both doses of the vaccines.
Read More
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