US grants emergency approval to Lilly Covid-19 antibodies
Brazil halts trials of Chinese Covid-19 vaccine: Pfizer vaccine ‘milestone’ hailed worldwide
The US Food and Drug Administration on Monday granted emergency approval to a synthetic antibody treatment against Covid-19 developed by Eli Lilly, after the drug was shown to reduce the risk of hospitalization and emergency room visits.
Bamlanivimab at a dose of 700 milligrams was authorized for the treatment of mild-to-moderate Covid-19 in adults and children aged 12 years and older who are at high risk for progressing to the severe form of the disease.
It is the first major drug to be approved that was designed specifically against the new coronavirus.
"As illustrated by today's action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments," said the agency's chief Stephen Hahn.
The approval was based on a mid-stage clinical trial for outpatients with mild to moderate Covid-19, where the intravenous treatment was shown to reduce viral loads and rates of symptoms and hospitalization.
The FDA said in its statement that the most important evidence that bamlanivimab may be effective came from data that showed that among patients at high risk of severe disease, hospitalizations and emergency room visits occurred in 3 percent of bamlanivimab-treated patients compared to 10 percent who were on the placebo.
The frequency and types of side effects were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity.
The most common were diarrhea, dizziness, headache, itchiness and vomiting.
The trial is ongoing and aims to enroll more than 800 patients across various dosage groups.
An important caveat is that bamlanivimab has not been authorized for patients who are hospitalized -- since no benefit has been shown for patients who are already in this late stage of the disease, when the body's immune defenses go into overdrive and damage organs.
The FDA wrote that administering the drug too late could be associated with worse outcomes, and a trial exploring bamlanivimab in hospitalized patients was suspended last month over a safety incident.
Bamlanivimab is what's known as a monoclonal antibody, a relatively new class of drugs that are best known for treating certain types of cancer and autoimmune disease.
Human immune systems produce antibodies, which are infection-fighting proteins, and vaccines teach our bodies to be prepared to make the right ones for particular pathogens.
Bamlanivimab was based on an effective antibody Lilly found in a recovered patient.
The host immune cells that produce the antibodies can be cultured in a lab to produce the desired proteins en masse.
It works by binding to a surface protein of the coronavirus to stop it from invading human cells.
Two new cases in White House
Two more people close to US President Donald Trump tested positive for the coronavirus, media reports said Monday.
Housing and Urban Development Secretary Ben Carson. 69, has contracted the virus, his deputy chief of staff Coalter Baker told NPR. "He is in good spirits and feels fortunate to have access to effective therapeutics which aid and markedly speed his recovery," Baker said in a statement.
According to ABC television, Carson was briefly treated at Walter Reid military hospital outside Washington DC, where Trump himself was treated for the virus.
Carson had spent Tuesday evening at the White House watching the election results come in.
Another top aide to the president, David Bossie, was also at the White House event and tested positive on Sunday and has been self-isolating at home, NBC news said.
Bossie, 55, was tapped a few days ago to lead the president's legal challenges to the election results.
On Friday, media reported that Trump's chief of staff Mark Meadows had tested positive for the disease after the election,. It was not clear when he contracted the virus.
The Washington Post said Meadows was in the crowd in the White House when Trump addressed around 150 of his staff and supporters on Wednesday.
Several leading members of the administration have contracted the virus in recent weeks, including Trump and his wife, First Lady Melania Trump.
The United States had recorded 238,000 deaths by Monday night and more than 10 million people have been infected.
The pandemic was one of the main issues in the battle for the White House between Trump and former vice president Joe Biden, whom media projected to have won on Saturday.
Brazil halts trials of Chinese vaccine
Brazil's health regulator said Monday it had suspended clinical trials of a Chinese-developed Covid-19 vaccine after an "adverse incident" involving a volunteer recipient, a blow for one of the most advanced vaccine candidates.
The setback for CoronaVac, developed by Chinese pharmaceutical firm Sinovac Biotech, came on the same day US pharmaceutical giant Pfizer said its own vaccine candidate had shown 90 percent effectiveness, sending global markets soaring and raising hopes of an end to the pandemic.
The Brazilian regulator, Anvisa, said in a statement it had "ruled to interrupt the clinical study of the CoronaVac vaccine after a serious adverse incident" on October 29.
It said it could not give details on what happened because of privacy regulations, but that such incidents included death, potentially fatal side effects, serious disability, hospitalization, birth defects and other "clinically significant events."
However, the public health center coordinating the trials of the vaccine in Brazil, the Butantan Institute, said it was "surprised" by the decision.
The institute "is investigating in detail what happened," and "is at the Brazilian regulatory agency's disposal to provide any clarification necessary on any adverse incident the clinical trials may have presented," it said.
It said it would hold a press conference on Tuesday at 11:00 am (1400 GMT).
CoronaVac has been caught up in a messy political battle in Brazil, where its most visible backer has been Sao Paulo Governor Joao Doria, a top opponent of far-right President Jair Bolsonaro.
The Sao Paulo state government said in a statement it "regrets that it learned of the decision from the press, instead of directly from Anvisa," and was waiting along with the Butantan Institute for more information on "the real reasons for the suspension."
- Pandemic politics -
Bolsonaro has labeled CoronaVac the vaccine from "that other country," and pushed instead for a rival vaccine developed by Oxford University and pharmaceutical firm AstraZeneca.
Last month, he shot down a plan by his own health minister to buy 46 million doses of CoronaVac, saying, "The Brazilian people will not be anyone's guinea pig," and referring to it as "Joao Doria's Chinese vaccine."
Doria announced earlier Monday that the first 120,000 doses of CoronaVac would arrive in Sao Paulo on November 20.
His state has a deal with Sinovac to buy a total of 46 million doses -- six million produced in China and the rest produced in Sao Paulo, which broke ground last week on a factory to make the vaccine domestically.
"Officials in the state government fear Bolsonaro will use technical decisions to delay the timeline of the vaccine for political reasons," newspaper Folha de Sao Paulo reported, citing unnamed Doria allies.
Anvisa told AFP it had no comment beyond its statement announcing the suspension, which said that halting trials was standard procedure in such cases.
Bolsonaro faces criticism for his handling of the pandemic, which has included downplaying the virus, opposing lockdown measures and relentlessly promoting the drug hydroxychloroquine despite studies showing it is ineffective against Covid-19.
Vaccine 'milestone' hailed as global Covid cases soar
One of the teams racing to develop a coronavirus vaccine announced Monday its drug had shown 90 percent effectiveness, sending markets soaring and raising hopes of an end to the worst pandemic in a century.
US pharmaceutical giant Pfizer said tests involving more than 40,000 people had provided results that were a "critical milestone" in the search for a vaccine, as global infections soared past 50 million -- including an alarming 10 million now in the United States alone.
Stock markets had already jumped after Democrat Joe Biden was called as the winner of the US presidential election on the weekend. They accelerated rapidly on the vaccine news, with the Dow Jones Industrial Average up three percent at Monday's close of trade.
An effective vaccine is seen as the best hope to break the cycle of deadly virus surges followed by severe restrictions across much of the world since Covid-19 first emerged in China late last year.
Tens of millions of people in Europe are living under lockdowns preventing them from leaving their homes, and millions of business owners are enduring forced closures.
- 'Much-needed breakthrough' -
Curbs on daily life have shredded the global economy but politicians have had few other tools to protect vulnerable populations.
"We are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis," Pfizer chairman Albert Bourla said in a statement.
The drug, being developed jointly with German firm BioNTech, is one of more than 40 candidate vaccines, but no other has yet made similar claims about its effectiveness.
The companies said they could pass the final hurdles for a US rollout later this month, and could supply up to 50 million doses globally this year and up to 1.3 billion next year.
The scientific community reacted positively, with top US expert Anthony Fauci describing the results as "extraordinary."
World Health Organization director Tedros Adhanom Ghebreyesus hailed the news as "encouraging" shortly after warning that the world "might be tired of Covid-19. But it is not tired of us."
But others pointed out that no information had yet been disclosed about the ages of the participants in the trial.
"If a vaccine is to reduce severe disease and death, and thus enable the population at large to return to their normal day-to-day lives, it will need to be effective in older and elderly members of our society," said Eleanor Riley, professor of immunology and infectious diseases at the University of Edinburgh.
- Biden task force -
Outgoing US President Donald Trump was among the first to react, writing on Twitter: "STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!"
He later claimed on Twitter that news of progress on a vaccine had been delayed until after the election to damage him.
Bamlanivimab, which was shown to reduce the risk of hospitalization and emergency room visits, is the first major drug to be approved that was designed specifically against the new coronavirus.
American voters handed victory to Biden in part because Trump failed to rein in the epidemic -- often refusing to back restrictive measures or even wear a mask in public and repeatedly undermining his own experts.
Biden, who will not take office until January, has already announced a taskforce to tackle Covid-19, as confirmed infections soared past 10 million and American deaths neared 238,000.
"We're still facing a very dark winter," he said. "The bottom line: I will spare no effort to turn this pandemic around once we're sworn in."
- 'Out of control' -
The vaccine news will be of particular relief to people in Europe -- the current focal point of the pandemic and the region subject to the most widespread restrictions.
The European Union said Monday it could soon sign a contract with Pfizer and BioNTech for 300 million doses of the new coronavirus vaccine.
"European science works!" declared Ursula von der Leyen, the president of the European Commission, congratulating the companies after they claimed a breakthrough.
On Monday, Ukrainian President Volodymyr Zelensky became the latest leader to test positive for the virus, with his office saying he felt well and would self-isolate and continue to work.
Italy was edging closer to a full lockdown, with experts warning of pressure on hospitals.
"There is no doubt that the situation is largely out of control," said Massimo Galli, head of the infectious diseases department at Milan's Sacco hospital.
Grim news kept coming elsewhere, with Russia surpassing its record for daily infections again Monday.
Hungary is now one of the hardest-hit countries in terms of deaths proportionate to its population, and the government announced new national restrictions to come into force Wednesday.
Portugal meanwhile entered a state of emergency that will see curfews imposed on most of the population.
In France, which has imposed nationwide stay-at-home orders and is clocking more than 40,000 cases a day, the central bank revised its expectations of the damage wrought by the curbs.
"Before the second wave, we thought the recession would be a little less than nine percent, we think today that for 2020 as a whole it will be between nine and 10 percent," Banque de France chief Francois Villeroy de Galhau said.