Berlin—As nations race to find a cure for the novel coronavirus, Germany has authorized its first clinical test of a vaccine for it, the country's regulatory body said Wednesday, green-lighting trials on human volunteers for an RNA vaccine developed by German firm Biontech and US giant Pfizer.
"The Paul-Ehrlich-Institut… has authorized the first clinical trial of a vaccine against COVID-19 in Germany," the regulatory body PEI said in a statement.
The trial, which was only the fourth to have been authorized worldwide, was a "significant step" in making a vaccine "available as soon as possible," the institute added.
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It said that approval was the "result of a careful assessment of the potential risk/benefit profile of the vaccine candidate."
The trials will see "200 healthy volunteers aged between 18 and 55 years" vaccinated with variants of the RNA vaccine, while the second phase could see the inclusion of volunteers who belonged to high-risk groups.
Neither PEI nor the developers specified when the trial will begin, though Biontech claimed in a statement that it would be "soon" and "ahead of our expectations."
The PEI also claimed that "further clinical trials of COVID-19 vaccine candidates will start in Germany in the next few months."
Meanwhile, the United Nations General Assembly has demanded equal access for any future COVID-19 vaccine but its seeming unanimity was a fluke. The United States, in fact, opposed the resolution but acted too late to stop it, diplomats say.
The 193 members of the General Assembly adopted by consensus Monday a resolution led by Mexico that calls for "equitable, efficient and timely" access to any vaccine developed to fight the pandemic.
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But the non-binding resolution irked the United States for another reason. It highlighted the "crucial leading role" of the World Health Organization, which President Donald Trump has strongly criticized for not doing more to halt the virus after it was detected in China.
The adoption of the text was announced three hours after the vote, an unusually long gap.
The reason for the delay, diplomats told AFP, was that the United States had tried unsuccessfully to block it after the fact.
There is no veto at the General Assembly, which includes every UN member state, unlike the more powerful Security Council where five powers— Britain, China, France, Russia, and the United States — can stop any resolution.
Also, a malaria drug widely touted as a potential cure for COVID-19 showed no benefit against the disease over standard care — and was in fact associated with more deaths, the biggest study of its kind showed Tuesday.
The US government-funded analysis of how American military veterans fared on hydroxychloroquine was posted on a medical preprint site and has not yet been peer-reviewed.
The experiment had several important limitations but adds to a growing body of doubt over the efficacy of the medicine that counts President Donald Trump and right wing news channel Fox News among its biggest backers.
Researchers looked at the medical records of 368 veterans hospitalized nationwide who either died or were discharged by April 11.
Death rates for patients on hydroxychloroquine were 28 percent, compared to 22 percent when it was taken with the antibiotic azithromycin — a combination favored by French scientist Didier Raoult, whose study on the subject in March triggered a surge of global interest in the drug.
The death rate for those receiving only standard care was 11 percent.
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In ordinary times, the General Assembly adopts resolutions either by consensus or by majority votes—displayed openly on an electronic board or held secretly in the case of elections.
But faced with the coronavirus pandemic, the General Assembly has changed its way of doing business until at least late May to avoid physical meetings at the UN headquarters in New York.
Under the temporary setup, a country puts forward a text which is adopted after a "period of silence" of several days in which any member can voice objections —effectively a veto.
The United States did not "break the silence" before Monday's deadline for the resolution—but, according to diplomats, tried to voice objections just afterward.
"One delegation wanted to break the silence after the silence," a diplomat told AFP, with another diplomat confirming the United States was the country.
The US mission at the United Nations did not respond to requests for comment. Trump has ramped up his broadsides against the WHO amid criticism at home over his handling of the crisis.
For the United Nations, the temporary procedures were seen as vital to ensure that texts, not to mention budgetary authorizations, can move forward.
But the arrangement effectively lets any one of 193 nations hold up the entire United Nations.
On April 3, no country broke the silence to stop a resolution that called in general terms for international cooperation to fight COVID-19.
But a separate bid the same day by Russia to urge the lifting of economic sanctions amid the pandemic was blocked by Ukraine, Georgia, the United States, and European Union.
Russia has moved forward this week with another resolution that targets sanctions. It calls on all nations to "face global challenges as good neighbors, refraining from implementing protectionist and discriminatory measures inconsistent with the World Trade Organization rules."
Member states have a deadline of 1600 GMT Wednesday to break the silence on the Russian draft — and most diplomats think that this time around, objections will be lodged in time.
On June 17, the General Assembly will have to tackle one of its thorniest issues — selecting five new non-permanent members to the Security Council.
Diplomats say that the candidates for Security Council seats — which include Canada, Djibouti, Ireland, Kenya, and Norway — are already voicing alarm on how the election can take place if the crisis restrictions remain in place.
