US grants emergency approval to COVID therapy used to treat President Trump
WASHINGTON/RIYADH — US drug regulators gave emergency approval to a COVID-19 antibody therapy on Saturday and G20 nations pushed for global access to vaccines as the pandemic led to further closures in parts of the world.
G20 nations emphasized the need for global access to coronavirus vaccines at a Saudi-hosted virtual summit Saturday dominated by efforts to tackle the pandemic and the worst global recession in decades.
World leaders, including US President Donald Trump who is refusing to concede a bitter election, popped up in multiple windows across a flickering screen, in a high-stakes webinar held amid the raging pandemic.
Trump, who continues to reject his election defeat, was briefly dialed into the meeting and “spoke about the aggressive actions and safety measures the United States took to protect the vulnerable, pioneer groundbreaking treatments, and develop vaccines and therapies at record-setting speed, which will save millions of lives,” according to a White House statement. He then went golfing.
The US president told his counterparts that any American who wants the vaccine will be able to get it, and singled out American producers Pfizer, Inc., whose vaccine has been developed along with a German company, and Moderna, Inc.
Trump praised American leadership, claiming credit for what he said was an efficient fight against the virus and success in bolstering the nation’s
economy.
But he said nothing about granting access to American vaccines by the rest of the world.
The leaders are huddling online for the two-day gathering as international efforts intensify for a large-scale rollout of coronavirus vaccines after a breakthrough in trials, and as calls grow for G20 nations to plug a $4.5-billion funding shortfall.
“Although we are optimistic about the progress made in developing vaccines, therapeutics and diagnostics tools for COVID-19, we must work to create the conditions for affordable and equitable access to these tools for all people,” said Saudi King Salman, the summit’s host.
“We have a duty to rise to the challenge together during this summit and give a strong message of hope and reassurance to our people by adopting policies to mitigate this crisis,” he told world leaders in opening remarks.
Chinese President Xi Jinping spoke of the need to build a “global firewall against COVID-19” as he called on G20 nations to help distribute vaccines “fairly and efficiently,” according to state news agency Xinhua.
And French President Emmanuel Macron said the health crisis was “a test for the G20,” stressing there “will be no effective response to the pandemic unless it is a global response.”
As the trailblazing event got under way, there had been some early quirks, with someone heard telling King Salman that “the whole world is watching” before the event started and Xi apparently having to call for technical help.
With Saudi hopes for a grand coming-out parade dashed due to the pandemic, the event has been reduced to brief online sessions of what observers call “digital diplomacy.”
Despite having to abandon much of the usual summit pageantry, Saudi Arabia launched the meeting with an aerial acrobatics display over Riyadh.
Along with Xi and Macron, Turkish President Recep Tayyip Erdogan also addressed the summit, where sources said climate change was among the issues topping the agenda.
Russian President Vladimir Putin said his country is ready to share its vaccines with others that need it.
Funding gap
G20 nations have contributed more than $21 billion to combat the pandemic, which has infected 56 million people globally and left 1.3 million dead, and injected $11 trillion to “safeguard” the virus-battered world economy, organizers said.
But the group’s leaders face mounting pressure to help stave off possible credit defaults across developing nations.
Last week, its finance ministers declared a “common framework” for an extended debt restructuring plan for virus-ravaged countries, but campaigners say the measure is insufficient.
The ministers had extended a debt suspension initiative for developing countries until June next year but UN Secretary-General Antonio Guterres has pushed for a commitment to push it until the end of 2021.
International Monetary Fund managing director Kristalina Georgieva has warned that the global economy faces a hard road back from the COVID-19 recession, even as vaccines are now in sight.
G20 nations must help plug the $4.5-billion funding gap in the so-called ACT-Accelerator, Norway’s prime minister, South Africa’s president and the heads of the European Union and the World Health Organization demanded in a joint letter to the group.
The program promotes an equitable distribution of COVID-19 vaccines including poor countries to rein in the pandemic.
Trump’s therapy
The antibody therapy approval in the United States offers some hope for those infected, though a relatively small number of doses will be available in the coming weeks.
The same therapy was used to treat President Donald Trump when he was
sickened with the virus.
The green light for drugmaker Regeneron came after REGEN-COV2, a combination of two lab-made antibodies, was shown to reduce COVID-19-related hospitalizations or emergency room visits in patients with underlying conditions.
“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said Stephen Hahn, commissioner of the US Food and Drug Administration.
Regeneron’s antibody treatment is the second synthetic antibody treatment to receive an emergency use approval (EUA) from the FDA after a similar therapy developed by Eli Lilly was granted the status on November 9.
The company said it expects to have doses ready for 80,000 patients by the end of November and approximately 300,000 patients in total by the end of January 2021.
These will be available to US patients at no out-of-pocket cost under the terms of a US government program.
But with cases surging across the US and globally, that means access will not be widespread. The US has added more than 360,000 new Covid-19 cases in the past two days alone.