The World Health Summit, one of global health’s premier policy conferences got underway today in the shadow of an escalating COVID-19 case surge across Europe. The surge saw WHS sessions shift to an all-virtual platform – after organizers were forced to shelve initial plans for limited in-person participation in Berlin, where the annual conference co-hosted by the German government, typically draws thousands of health policymakers, experts and researchers from government, academia and industry.   

“COVID-19 is shining a light on the decisions we and policy makers are making, not only today, but also in the past,” said WHO’s Director General Dr. Tedros Adhanom Ghebreyesus, at Sunday’s opening ceremony, in a session that included UN Secretary-General Antonio Guterres and European Commission President Ursula von der Leyen. 

“The virus thrives in the inequalities in our societies, and the gaps in our health systems. The pandemic has highlighted the neglect of basic health system functions underpinning emergency preparedness – to disastrous consequences,” Dr Tedros added. 

His comments echoed key themes in this year’s conference, which is focusing on pandemic preparedness and responses in multiple dimensions. Themes will touch on oft-polarized debates over vaccine nationalism and access to medicines  – as well as exploring more technical issues such as digital health and disease surveillance.  The conference will also touch on the broader context in which the pandemic has unfolded, including accelerating climate change and increasing non-communicable disease rates, which also make people more vulnerable to COVID-19. 

Repeating an oft-stated message, The WHO Director General underlined that robust health systems are the foundation of response now and preparedness tomorrow: “Of course, this pandemic is playing out differently in every country and in every community. But there are some constants,” said Dr Tedros. “Health systems, matter preparedness matters and doctors, nurses and health workers must have the training and equipment they need. This have been fundamental to how countries and communities are weathering this pandemic. ….Public Health is more than medicine and science. And it’s bigger than any individual, ultimately, it’s a matter of leadership at the question of political choice.”

“Vaccine Nationalism” Will Prolong Pandemic  

The WHO Director General also called upon countries to shun “vaccine nationalism” and support an equitable distribution of COVID-19 vaccines, once they become available, particularly in light of the unprecedented threat that COVID-19 poses worldwide. 

“Let me be clear, vaccine nationalism will prolong the pandemic, not shorten it,” said Dr Tedros. 

“It’s natural that countries want to protect their own citizens first. But if and when we have an effective vaccine, we must also use it effectively. And the best way to do that is to vaccinate some people in all countries rather than all people in some countries. 

“I will repeat. The best way to do that is vaccinate some people in all countries, rather than all people in some countries,” he said. 

UNAIDS – Vaccines Should Be ‘Public Goods’  

Speaking at the opener, UNAIDS Executive Director Winnie Byanyima echoed the WHO call on equitable distribution of future COVID-19 vaccines and went further – saying that the therapies  must be a “peoples’ vaccine” in order to be and fairly distributed. “To do this, pharma companies must openly share their know-how and technology for producing the vaccines” as opposed to holding onto “patent monopolies.” 

The fight against COVID-19 must be one that “places human rights at the heart of the response to the crisis, she added, citing past pandemics like the HIV/AIDS crisis of two decades ago, as an example: 

“Through the AIDS/HIV crisis, there was a global HIV response that has allowed 25 million people to get on life saving HIV treatment to live full lives. 

“Only bold and radical policy action will get us out of crises like this. Nothing less than that can work,” stated Byanyima.

“We can beat COVID-19, we can beat inequality, we can finish the unfinished business of AIDS and also repair and restore the global economy, but only without people centered, public health, rights based approach.

“The most important drivers of change during the AIDS epidemic were not those in authority, but rather, those most affected, who can bring insight, practical innovations, as well as the truth needed to guide leaders and countries forward,” she added. “To do that, governments must acknowledge that COVID-19 vaccine tests and treatments are public goods.” 

Race Towards Vaccine is a Race Against the Virus, Not Pharma Companies, says Sanofi CEO

But global leaders calling for radical action also need to remember that the world is engaged in a “race against the virus,” and companies are part of the solution, not the problem, said Sanofi CEO Paul Hudson, which is developing a messengerRNA (mRNA) vaccine candidate together with GSK, currently in Phase 2 trials. 

Hudson said that the company is committed to ensuring affordable and accessible distribution of any vaccines or health products that they produce – including “providing a significant proportion of our total worldwide available supply to COVAX,” he said, referring to the WHO global vaccine procurement facility to which over 180 countries have signed on .

“The race is not between companies; it’s against the virus,” said Hudson. 

He added that Sanofi also is collaborating with the European Union to build more resilience into the regional and global health products supply chain, in the wake of supply chain interruptions at the start of the pandemic, and consequent tensions between countries. The steps include co-creation of an  “European and global champion dedicated to the production of active pharmaceutical ingredients,” he said, “The crisis we face should not lead us to take further protectionist measures. What we need to ensure is building resilience and strategic health autonomy.” 

But he added that it’s also critical that governments around the world invest in stronger healthcare systems and infrastructure – otherwise medicines still will not reach those people who need them. 

“It is fundamental that governments around the world, despite all the headwinds, continue to invest in healthcare systems and infrastructure. We know that today almost half the world population still lacks access to essential health services.”

Added Nanette Cocero, President of Pfizer Vaccines, routine health services also need to be maintained, such as life-saving vaccinations  against existing preventable diseases. 

“Prioritizing vaccination against disease that is already preventable protects the most vulnerable among us, from newborns in maternity hospitals to older adults, for whom illnesses like seasonal flu and pneumococcal diseases pose a serious danger and disruption of immunization services” she said, adding that even “brief” interruptions can increase the likelihood of  outbreaks for highly contagious diseases like measles.” 

Added Von der leyen, the broader context of health also needs a closer look. Sounding notes on other themes such as climate change, which are also being featured at this year’s Summit, she said. “In today’s world, we need to look after our health by looking after our planet, our well being and our sustainable development. And we need to do it together through global health cooperation and not through global health competition.” 

Image Credits: R Santos/HP Watch.

The United States Food and Drug Administration decision Thursday to approve Gilead Science’s Remdesivir as a COVID-19 treatment failed to consider the results of the recent WHO “Solidarity Trial”  – which found no measurable benefits for the drug’s use – because the pharma company failed to include the study in its FDA submission for approval,  WHO’s Chief Scientist said on Friday.   

Speaking at a WHO press conference, Soumya Swaminathan also said that she hoped to see  results from “one or two” viable COVID-19 vaccine candidates emerging by the end of this year. But like other experts, she cautioned that even if all goes well, a vaccine would only likely become available in the first quarter of 2021 to the highest risk groups – like health workers. 

“Certainly in early 2021, I think we’re going to start seeing more and more results coming out.  And somewhere in the first quarter of 2021, we’re talking about the world, there may be some vaccines available for the most high-risk groups in countries around the world,” said Swaminathan, repeating a frequent WHO call that the initial, limited supplies should be fairly distributed with front-line health workers around the world getting access first.

Gilead Sciences Omitted WHO’s Evidence That Remdesivir Doesn’t Work From Its FDA Submission  

In terms of GIlead’s omission of the WHO evidence on Remdesivir, Swaminathan said that WHO provided the results of its Solidarity Trial, the largest of the drug in the world, to Gilead Pharmaceuticals on 28 September, even before they had been publicly announced on 16 October by WHO:  “but it appears that the Solidarity results were not considered, were not provided to the FDA.” 

She also said: “What we understand from the FDA decision yesterday was that it was based on data submitted to them from Gilead, which did not include the Solidarity Trial results.”  

The WHO Solidarity trial is the largest in the world to have been conducted on the experimental treatment, which was originally developed for Ebola but never approved. The WHO Solidarity Trial of the drug’s use against the SARS-CoV-2 virus that causes COVID-19 involved 5000 patients around the world, who were randomized to administration of the drug or the standard of care. 

Even though the WHO sponsored trial was not double blinded – investigators knew which patients were being administered the drug or not, it was still “very robust” Swaminathan said, “because we looked at endpoints like mortality, like death, which is not a soft endpoint. Its not something you can fudge. We looked at progression to ventilation, which is again, very objective,” she said. 

“We looked at very important endpoints, like hospital mortality. No difference. Progression to ventilation – 92% of the people who entered this trial were not on mechanical ventilation… we looked at how many of those progressed to need ventilation. There were exactly the same numbers in the Remdesivir and the control arm…. ”

The trial also looked at the proportion of patients discharged from hospital after seven days – and there again, there was “no difference in those proportions” for people receiving Remdesivir and those receiving a standard of care, she said.   

US FDA Decision Anchored in NIAID Trial

The US FDA decision Thursday, announced as the “first treatment for COVID-19” to be fully approved by the agency, appeared to be largely anchored in the results of two clinical trials sponsored by Gilead, which showed varying degrees of symptomatic improvement for people administered the drug, as well as a trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID), with over 1,000 patients in spring 2020, which found slight benefits for people using the drug in terms of their “time to recovery”.  

Of the latter, the US FDA statement said the NIAID trial evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated:

“The trial looked at 1,062 hospitalized subjects with mild, moderate and severe COVID-19 who received Veklury (n=541) or placebo (n=521), plus standard of care. Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care.

“The median time to recovery from COVID-19 was 10 days for the Veklury [Remdesivir] group compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group.

Said Swaminathan of the NIAID trial and others, “Recovery was defined in a number of ways, but it was based on how patients were feeling, whether they needed oxygen, and whether they needed hospitalization.” 

Despite Gilead Pass – WHO To Incorporate Solidarity Trial Findings in Updated Global Treatment Guidelines

Despite the fact that the Solidarity findings on Remdesivir were ignored in the US FDA approval process, WHO will be incorporating the results into an updated set of global treatment guidelines that should be issued within the next several weeks.  The Solidarity Trial also tested the efficacy of three other treatments including hydroxychloroquine, Interferon and the HIV combination drug Lopinavir-Ritonavir – all of which have fallen by the wayside as well. Conversely, WHO says, the inexpensive generic drug, dexemethasone, has been demonstrated to reduce mortality by a third among critically-ill COVID-19 patients, in a UK trial, and has been strongly recommended by WHO for use in severe and critically ill patients.   

“We believe our results are very robust, and we hope that people who are doing treatment guidelines around the world as well as regulators around the world will take note of the study results, in addition to the other evidence – because you need to look at the global evidence for a drug before you make decisions,” said Swaminathan. 

COVID-19 Infection Trends Have Countries on ‘Dangerous’ Track, Warns WHO Director General

Meanwhile, WHO Director General Dr Tedros Adhanom Ghebreyesus warned that current COVID-19 infection trends in the northern hemiphere are on a “dangerous track” -saying that countries need to choose between the “the good, the bad and the ugly” in shaping their responses.

“The next few months are going to be very tough and some countries are on a dangerous track,” Ghebreyesus warned. 

“Too many countries are seeing an exponential increase in cases and that’s now leading to hospitals and ICUs running close. or above, capacity and we’re still only in October. We urge leaders to take immediate action to prevent further unnecessary deaths, essential services from collapsing, and schools shutting again.

“As I said in February, and I am repeating it today, this is not a drill.” 

In shaping responses, countries need to “consider the good, the bad and the ugly”, he added saying that for countries that have got COVID-19 under control, “now is the time to double down”. For those countries seeing infection rates soaring out of control, he urged politicians to “make the necesssary changes and correct course; making changes when needed shows leadership and strength.”

The WHO Director General added that public support also needs to be proffered to shield households from the worst economic fallout of COVID-19: “That means if people are told to isolate or quarantine, or businesses have to close temporarily, governments need to do everything they can to assist individuals, famlies and businesses.” 

Image Credits: WHO, ChiralJon – Remdesivir 3D.