Medical journal editorial refutes WHO finding on Gilead's remdesivir for COVID-19

 An editorial in the influential New England Journal of Medicine cites problems with a World Health Organization (WHO) study that found Gilead Sciences Inc's antiviral remdesivir failed to improve COVID-19 survival, and said it does not refute trials that demonstrated benefits of the drug in treating the illness.

The editorial, by David Harrington at the Harvard T.H. Chan School of Public Health, infectious disease specialist Dr. Lindsey Baden and Brown University biostatistician Joseph Hogan, was published on Wednesday along with the WHO study.

They noted that the trial called Solidarity, which looked at four drugs, was conducted in 30 countries ranging from Switzerland and Germany to Iran and Kenya, leading to inconsistencies in the data collected.

The findings are complicated by the fact that there is "variation within and between countries in the standard of care and in the burden of disease in patients who arrive at hospitals," they write.

Solidarity also found no COVID-19 survival benefit from treatment with the HIV drug lopinavir, the immune booster interferon or hydroxychloroquine, a malaria drug championed by U.S. President Donald Trump despite a lack of evidence of benefit in COVID-19.

The release in October of the trial's summary findings sparked a reevaluation by some of the utility of remdesivir, which was shown to shorten COVID-19 hospitals stays by five days compared with a placebo in an earlier U.S. government-run trial.

Solidarity "did not collect or report the standard of care or the healthcare system capacity in any of the 400 hospitals from 30 countries," said Dr. Andre Kalil, infectious disease specialist at the University of Nebraska Medical Center and lead investigator of the U.S. trial.

"If the basic supportive care is scarce or inadequate, no treatment drug will show much benefit even if known to be effective, because the adequate supportive care is essential for the survival of patients hospitalized with COVID-19," he said.

The WHO last month declared that remdesivir, which is given as an intravenous infusion, should not be used for patients hospitalized with COVID-19, regardless of how ill they are, since there is no evidence that it can improve survival or reduce the need for mechanical ventilation.

The U.S. Food and Drug Administration in October approved remdesivir, which is sold under the brand name Veklury, for COVID-19 patients over the age of 12 who require hospitalization. The drug is authorized or approved for use as a COVID-19 treatment in more than 50 countries.

Both the U.S. Infectious Diseases Society of America and the National Institutes of Health, which conducted the U.S. study, in recent weeks reaffirmed their guidelines for use of remdesivir following the FDA's full approval of the drug.

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-Sciences-Medical-journal-editorial-refutes-WHO-finding-on-Gilead-s-remdesivir-for-COVID-19-31924327/

Putin orders Russia begin large-scale COVID-19 vaccinations next week

 President Vladimir Putin ordered a large-scale voluntary vaccination programme against COVID-19 to begin next week across Russia, saying teachers and doctors should be first in line to get the country’s flagship Sputnik V vaccine.

Putin gave the order during an online meeting with ministers on Wednesday, a day when Russia, which has the fourth highest number of recorded infections in the world, registered 589 new daily deaths from the coronavirus.

Putin said Russia will have produced 2 million vaccine doses within the next few days.

Sputnik V, one of two Russian-made vaccines to have received domestic regulatory approval so far despite clinical trials being incomplete, requires two injections. A third vaccine is in also in the works.

Russia said last month that the Sputnik jab was 92% effective at protecting people from COVID-19 according to interim results.

“Let’s agree on this - you will not report to me next week, but you will start large-scale vaccination... Let’s get to work already,” Putin told Deputy Prime Minister Tatiana Golikova.

“I understand that you’re using very careful language and it’s absolutely right that we are cautious. But I know that industry and the (health) network are in general ready. Let’s take this first step.”

Russia has already vaccinated more than 100,000 high-risk people, Health Minister Mikhail Murashko said during a separate presentation to the United Nations about Sputnik V.

According to the presentation, more than 45,000 people are currently participating in Sputnik V trials worldwide.

The rise in infections in Russia has slowed since reaching a high on Nov. 27, with 25,345 new daily cases reported on Wednesday.

Russia has resisted imposing lockdowns during the second wave of the virus, preferring targeted regional curbs.

‘ABSOLUTE PRIORITY’

The Kremlin earlier gave assurances that Russians were first in line to be vaccinated, with Moscow also discussing supply deals with other countries.

“The absolute priority is Russians,” Kremlin spokesman Dmitry Peskov said. “Production within Russia, which is already being developed, will meet the needs of Russians.”

Authorities in St Petersburg, which reported 3,684 new infections on Wednesday, ordered bars and restaurants to close from Dec. 30 until Jan. 3, to combat the rise in cases there, the RIA news agency reported.

Museums, theatres and concert halls would be closed to the public in the city of more than 5 million people for the duration of Russia’s New Year holidays, from Dec. 30 to Jan. 10.

In Moscow, a remote learning period for secondary school students was extended beyond Dec. 6 to the end of the year.

With 2,347,401 infections, Russia only has fewer COVID-19 cases than the United States, India and Brazil. It has recorded 41,053 deaths related to COVID-19 since the start of the pandemic.

https://www.reuters.com/article/us-health-coronavirus-russia-putin/putin-orders-russia-to-begin-large-scale-covid-19-vaccinations-next-week-idUSKBN28C21E

US: U.N. COVID-19 meeting is stage for Chinese propaganda

 The United States on Wednesday claimed a United Nations meeting of world leaders on the COVID-19 pandemic was being designed to allow Beijing to spread propaganda, stoking months of bickering at the world body between the superpowers.

The two-day meeting of the U.N. General Assembly begins Thursday with some 53 heads of state, 39 heads of government and 38 ministers due to make pre-recorded video statements, including U.S. Health and Human Services Secretary Alex Azar and China’s Foreign Minister Wang Yi.

A senior U.S. official, speaking on condition of anonymity, said the special session of the 193-member General Assembly should have been held earlier, that it had been “pre-engineered to serve China’s purposes” and complained that questions at panel discussions on Friday would be restricted.

China would use the setting to its advantage, the official said, adding, “I expect them to make a very, very effective propaganda play out of these two days.”

A spokesperson for China’s mission to the United Nations in New York said the U.S. “politicization of the issue is not in the interest of the international community.”

Without naming the United States, the spokesperson said: “If certain a country insists, it will once again find itself isolated and end in failure. China will strengthen communication and collaboration with other member states and make positive and constructive contributions.”

U.S. President Donald Trump cut funding to the World Health Organization (WHO) earlier this year and announced plans to quit the Geneva-based body over accusations it was a puppet of China, which the WHO denied. The U.S. withdrawal would have taken effect in July next year, but U.S. President-elect Joe Biden said he will rescind the move.

Trump administration officials said they expected Beijing to push a narrative at the United Nations this week that the virus existed abroad before it was discovered in the Chinese city of Wuhan last year, a claim the WHO has called “highly speculative.”

Long-simmering tensions between the United States and China hit boiling point over the pandemic at the United Nations, spotlighting Beijing’s bid for greater multilateral influence in a challenge to Washington’s traditional leadership.

‘ALREADY TOO LATE’

Azar will not attack China directly in his video statement, but took aim at what he called a lack of “necessary information sharing” about the outbreak, according to a text of his prepared remarks. “This dereliction of duty has been absolutely devastating for the entire globe,” Azar said.

China has denied the U.S. assertions that a lack of transparency worsened the global outbreak.

The senior U.S. official, who spoke to Reuters on the condition of anonymity, underscored the severity of the pandemic: “I’m not going to call it a weapon of war, but we have to regard it as a serious threat. It is in fact the threat to international peace and security.”

Chinese scientists are carrying out research into the origins of the coronavirus and a WHO-led international team formed in September will develop plans for longer-term studies building on China’s findings.

The U.S. official also said it was “wholly unacceptable” that the WHO probe would not be completed for nearly a year.

Britain has called for prioritizing the investigation and ensuring its outcome is grounded in “robust science,” while Germany, speaking for the European Union, has called for “full transparency and cooperation” throughout the investigation.

The U.N. General Assembly agreed in October to hold the COVID-19 special session by adopting a resolution with 150 votes in favor. The United States, Israel and Armenia abstained and the remaining members didn’t vote. The meeting was proposed by the General Assembly president, Turkish diplomat Volkan Bozkir.

Bozkir’s spokesman Brenden Varma said the president thought that the meeting was “already too late” and should have happened in the summer. Varma added the meeting was created as a way to promote multilateralism in a time of crisis.

The point is “to bring countries together, along with U.N. actors, with the private sector, with vaccine developers to work together ... to take stock and to identify gaps and challenges,” Varma said.

https://www.reuters.com/article/health-coronavirus-un-usa/u-s-says-u-n-covid-19-meeting-is-stage-for-chinese-propaganda-idUSKBN28C3CB

U.N. drug agency loosens global controls on cannabis, following WHO advic

 The U.N. drug agency’s member states on Wednesday narrowly voted to remove cannabis from the most tightly controlled category of narcotic drugs, following the World Health Organization’s recommendation to make research into its medical use easier.

The annual Commission on Narcotic Drugs, the U.N. Office on Drugs and Crime’s governing body, voted 27-25 with one abstention to remove cannabis and cannabis resin from Schedule IV of the 1961 Single Convention on Narcotic Drugs, a global text governing drug controls, a U.N. statement said.

The vote followed a 2019 WHO recommendation that “cannabis and cannabis resin should be scheduled at a level of control that will prevent harm caused by cannabis use and at the same time will not act as a barrier to access and to research and development of cannabis-related preparation for medical use.”

Other drugs in Schedule IV include heroin, fentanyl analogues and other opioids that are dangerous and often deadly. Cannabis, by contrast carries no significant risk of death and it has shown potential in treating pain and conditions such as epilepsy, the WHO found.

The U.N. statement on the meeting in Vienna of the Commission on Narcotic Drugs did not say which countries backed or opposed the change, or why the vote was so close.

The convention states that a party to it will take “any special measures of control which in its opinion are necessary having regard to the particularly dangerous properties” of a drug listed in Schedule IV.

Schedule I, the next strictest level of control, which includes cocaine, does not carry that stipulation. The WHO recommended that cannabis still be listed there, noting “the high rates of public health problems arising from cannabis use.”

The commission did not, however, back other WHO recommendations, such as removing “extracts and tinctures of cannabis” from Schedule I, the statement said.

https://www.reuters.com/article/us-un-drugs-cannabis/u-n-drug-agency-loosens-global-controls-on-cannabis-following-who-advice-idUSKBN28C32L

Lilly to supply 650,000 more doses of COVID-19 antibody drug to U.S. govt.

 Eli Lilly and Co said on Wednesday the U.S. government has purchased 650,000 additional doses of its COVID-19 antibody drug for $812.5 million.

The doses will be delivered through Jan. 31, with at least 350,000 delivered in December, the company said.

https://www.reuters.com/article/us-health-coronavirus-lilly/lilly-to-supply-650000-more-doses-of-covid-19-antibody-drug-to-u-s-government-idUSKBN28C3AO

Moderna CEO sees emergency nod for COVID-19 vax shortly after FDA Dec. 17 meet

 Moderna Inc’s COVID-19 vaccine could be approved for emergency use within 24 to 72 hours after the U.S. health regulator’s advisory committee meeting, Chief Executive Officer Stéphane Bancel said on Wednesday.

The Food and Drug Administration is scheduled to hold the meeting on Dec. 17 to discuss the company’s request for emergency use authorization for its vaccine.

Moderna currently has millions of doses of vaccines that can be shipped as soon as its request is granted, Bancel said, while speaking at the Piper Sandler healthcare conference.

Moderna, which is one of the front-runners in the race to develop a coronavirus vaccine, has applied for emergency authorizations both in the United States and the EU after full results from a late-stage study showed its vaccine was 94.1% effective with no serious safety concerns.

A shot developed by Pfizer Inc and BioNTech SE that was 95% effective in its pivotal trial is set to be reviewed by a panel of outside experts a week earlier. The FDA will decide on the authorizations after the advisers make their recommendations.

Bancel said Moderna was in a position to ramp up production quickly and would generate a lot of cash next year.

“We have the platform, and now is the time to scale,” he said.

Moderna shares were up 1% at $142.47. They have risen more than seven-fold this year, valuing the company at $55.80 billion as of Tuesday’s closing price.

https://www.reuters.com/article/us-health-coronavirus-moderna-vaccine/moderna-ceo-expects-emergency-use-nod-for-covid-19-vaccine-shortly-after-fdas-december-17-meet-idUSKBN28C28U

AstraZeneca U.S. COVID-19 vaccine trial results likely late January: Slaoui

 AstraZeneca Plc will likely get results of its U.S. COVID-19 vaccine trial in late-January and could potentially file for an emergency authorization, the chief adviser for the U.S. government’s Operation Warp Speed program said on Wednesday.

The British drugmaker and Oxford University have already published interim efficacy results from their UK trial in November, but the results have raised questions among scientists.

The company said the vaccine could be 90% effective when given as a half dose followed by a full dose, based on a relatively small number of volunteers, while overall effectiveness was around 70%.

Speaking at a U.S. Department of Health and Human Services meeting, OWS chief adviser Moncef Slaoui said the large set of contrasting data coming out from the UK and Brazil trials may not be enough to ensure the vaccine receives the U.S. Food and Drug Administration’s emergency use authorization.

“Unless there is a very clear explanation based on facts and data of what’s behind those two numbers (on efficacy), it’s very likely that package would not be sufficient for (FDA) approval,” he said.

AstraZeneca resumed its U.S. trial in October after halting the study on Sept. 6 after a report of a serious neurological illness in a participant in the UK.

“I still expect that somewhere in January maybe, more towards the second half of January, data will become available and potentially an emergency use authorization could be filed,” Slaoui said, referring to the U.S. trial.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-vaccin/astrazeneca-u-s-covid-19-vaccine-trial-results-likely-in-late-jan-says-health-official-idUSKBN28C349