Virus drug nod possible by summer

Sanofi walks back after saying US would get vaccine first

LONDON, May 14, (AP): The European Medicines Agency predicted that there could be licensed drugs to treat the new coronavirus in the next few months and that a vaccine might even be approved in early 2021, in a “best-case scenario.”

Dr. Marco Cavaleri, who heads the European regulator’s vaccines department, told a media briefing on Thursday that approving medicines to treat COVID-19 might be possible “before the summer,” citing ongoing clinical trials. Recent early results for the drug remdesivir suggested it could help patients recover from the coronavirus faster, although longer-term data is still needed to confirm any benefit.

Although it typically takes years to develop a vaccine, Cavaleri said that if some of the shots already being tested prove to be effective, they could be licensed as early as the beginning of next year. Cavaleri cautioned, however, that many experimental vaccines never make it to the end and that there are often delays. “But we can see the possibility that if everything goes as planned, vaccines could be approved a year from now,” he said. More than 140 heads of states and health experts, including South African President Cyril Ramaphosa, Pakistani Prime Minister Imran Khan and Nobel laureate Joseph Stiglitz issued an appeal Thursday calling on all countries to unite behind a “people’s vaccine” against COVID-19, to ensure any effective treatments and vaccines be available globally to anyone who needs them, for free.

At the moment, there are about a dozen vaccine candidates being tested in China, Britain, Germany and the U.S. The World Health Organization has estimated it could take about 12 to 18 months for an effective vaccine to be found.

While some experts have proposed dropping the requirement for large-scale advanced clinical trials altogether, Cavaleri said that wasn’t currently being considered.

“Our current thinking is all vaccines under development should undergo large phase 3 trials to establish what is the level of protection,” he said.

But he acknowledged that could change if the situation worsened.

“Things may evolve as the pandemic will evolve and we will see if we need to do something else,” Cavaleri said.

Some officials have warned that a vaccine might never be found; previous attempts to develop a vaccine against related coronaviruses like SARS and MERS have all failed. But Cavleri was optimistic an immunization against COVID-19 would eventually be discovered, as there are various technologies being tried globally.

“I think it’s a bit early to say, but we have good reason to be sufficiently optimistic that at the end of the day, some vaccines will make it,” he said.

Sanofi walks back

French pharmaceutical group Sanofi ensured Thursday that it would make its COVID-19 vaccine, when ready, available in all countries, hours after the company’s CEO said the United States will get first access.

Sanofi CEO Paul Hudson’s comments prompted angry reaction from the French government.

Junior economy minister Agnes Pannier-Runacher said on Sud Radio “to us, it would be unacceptable that a country would get privileged access under the pretext of money reasons.”

In a statement released Thursday, Sanofi said “we have always been committed in these unprecedented circumstances to make our vaccine accessible to everyone.”

Sanofi said its cooperation with U.S. agency BARDA allows the company “to initiate production as early as possible.” The Biomedical Advanced Research and Development Authority has funded the development of the vaccine.

Hudson had previously told Bloomberg news agency that the U.S. would get first access to the French company’s COVID-19 vaccine.

“The U.S. government has the right to the largest pre-order because it’s invested in taking the risk,” he said.

Sanofi is pushing for “similar measures” to be taken in the European Union to accelerate vaccine development and access to the population.

“We are having very constructive conversations with the EU institutions and the French and German government among others,” the statement writes.

The president of Sanofi France, Olivier Bogillot, told broadcaster France Info that the U.S. are accelerating regulatory requirements to develop and produce a vaccine.

“Europe needs to do the same thing,” he said.

Dozens of vaccine candidates in earlier stages of development are being pursued around the world, yet a vaccine is likely to be a year or more away.

UN warns of ‘suffering’

U.N. Secretary-General Antonio Guterres urged governments, civil society and health authorities to urgently address mental health needs arising from the coronavirus pandemic, warning that psychological suffering is increasing.

The U.N. chief said in a video message launching a policy briefing that “after decades of neglect and under-investment in mental health services, the COVID-19 pandemic is now hitting families and communities with additional mental stress.”

He pointed to “grief at the loss of loved ones, shock at the loss of jobs, isolation and restrictions on movement, difficult family dynamics, and uncertainty and fear for the future.”

Guterres said those most at risk and in need of help are front-line health care workers, older people, adolescents, young people, those with preexisting mental health conditions, and those caught up in conflict and crisis.

“Mental health services are an essential part of all government responses to COVID-19,” he said. “They must be expanded and fully funded.”

The 17-page UN briefing stressed that “the mental health and well-being of whole societies have been severely impacted by this crisis and are a priority to be addressed urgently.”

The UN said “a long-term upsurge in the number and severity of mental health problems is likely” and warned that if action isn’t taken COVID-19 “has the seeds of a major mental health crisis” as well as “a physical health crisis.”

The briefing cited widespread psychological distress from the immediate health aspects of the virus, the consequences of physical isolation, fear of infection, dying and losing family members, physical distancing from loved ones and peers, and economic turmoil.

“Frequent misinformation and rumors about the virus and deep uncertainty about the future are common sources of distress,” the UN briefing said.

“In every community, there are numerous older adults and people with preexisting health conditions who are terrified and lonely,” it said. “Emotional difficulties among children and adolescents are exacerbated by family stress, social isolation, with some facing increased abuse, disrupted education and uncertainty about their futures.”