Second COVID Vaccine Trial Paused for Unexplained IllnessBy Robin Foster and E.J. Mundell
TUESDAY, Oct. 13, 2020 (HealthDay News) -- A second coronavirus vaccine trial was paused on Monday after an unexplained illness surfaced in one of the trial's volunteers.
Johnson & Johnson, which only began a phase 3 trial of its vaccine last month, did not offer any more details on the illness and did not say whether the sick participant had received the vaccine or a placebo. The trial pause was first reported by the health news website STAT.
While Johnson & Johnson was behind several of its competitors in the vaccine race, its candidate has an advantage in that it doesn't need to be frozen and it could be given in one dose instead of two, The New York Times reported. The J&J vaccine is also the focus of the largest COVID-19 vaccine trial, with a goal of enrolling 60,000 volunteers.
"Adverse events -- illnesses, accidents, etc. -- even those that are serious, are an expected part of any clinical study, especially large studies," the company said in a statement. "We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information."
"It's actually a good thing that these companies are pausing these trials when these things come up," Dr. Phyllis Tien, an infectious disease physician at the University of California, San Francisco, a vaccine trial site for both Johnson & Johnson and AstraZeneca, told the Times. "We just need to let the sponsor and the safety board do their review and let us know their findings."
Another expert agreed. "It doesn't mean that the adverse event is related to the vaccine, but it needs to be investigated thoroughly," said Dr. Luciana Borio, who oversaw public health preparedness for the National Security Council under President Donald Trump and was acting chief scientist at the U.S. Food and Drug Administration under former President Barack Obama. Depending on the findings, more data may be collected, trial rules may be changed, or other safety steps may be taken, she told the Times.
Johnson & Johnson is not the first company to pause a coronavirus vaccine trial. Two participants in AstraZeneca's trial became seriously ill after getting its vaccine. That trial has been halted and has not yet resumed in the United States.
Experts said safety issues must be investigated and are one reason late-stage trials cannot be rushed, even if Trump has repeatedly claimed that a vaccine will be ready before Election Day on Nov. 3.
"This kind of event epitomizes why vaccine development can't be influenced by artificial timelines such as an election," John Moore, a virologist at Weill Cornell Medicine in New York City, told the Times.
Two companies seek emergency approval for antibody cocktails
Regeneron Pharmaceuticals Inc. said last week that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to Trump shortly after he was diagnosed with COVID-19.
Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an "unbelievable" effect on his recovery from coronavirus infection, the Washington Post reported.
"I think this was the key," Trump said, after acknowledging that the antibody cocktail was just one of several drugs he was prescribed by his medical team. While there is no hard evidence yet proving the drug's effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.
In his video, Trump said, "I have emergency-use authorization all set, and we've got to get it signed now." However, an FDA spokeswoman told the Times that the agency does not confirm or deny product applications.
Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients, and then ramp production up to doses for 300,000 patients in the next few months if granted emergency authorization.
The antibody cocktail is now in late-stage testing. The company has granted fewer than 10 "compassionate use" requests allowing people not enrolled in its trials to use the drug, the Associated Press reported.
The U.S. government first inked a contract with Regeneron back in July, and has promised to distribute initial doses of the treatment at no cost if it is approved, the Post reported.
Regeneron isn't the only company developing an antibody cocktail to battle COVID-19 infection: Eli Lilly and Co. has also announced that it is seeking emergency-use authorization from the FDA for a similar cocktail. Both treatments use lab-made antibodies to give patients' immune systems a boost. In both cases, scaling up production to meet demand is expected to be a major challenge, the Post reported.
COVID continues to spread around the globe
By Tuesday, the U.S. coronavirus case count passed 7.8 million while the death toll neared 215,000, according to a Times tally.
According to the same tally, the top five states in coronavirus cases as of Tuesday were: California with nearly 860,000; Texas with more than 836,000; Florida with over 736,000; New York with over 480,000; and Illinois with more than 325,700.
Curbing the spread of the coronavirus in the rest of the world remains challenging.
Several European countries are experiencing case surges as they struggle with a second wave of coronavirus infections and hospital beds begin to fill up, the Post reported.
In England, Prime Minister Boris Johnson instituted a three-tier lockdown in a bid to slow a startling spike in coronavirus cases across the country. In the past three weeks, new coronavirus cases have quadrupled and there are now more COVID-19 patients hospitalized than before the government imposed a lockdown back in March, the Post reported.
Chris Whitty, England's chief medical officer, admitted Monday that he was not convinced that the rules in the strictest tier "would be enough to get on top of" the virus, the Post reported.
With the city of Liverpool to face the strictest of measures under Tier 3 on Wednesday, Housing Secretary Robert Jenrick said the government may "need to go further" to control the second outbreak.
The majority of England remains on medium-level alert, meaning six people can meet up and restaurants remain open but all have to obey a 10 p.m. curfew, the Post reported.
Addressing the nation on Monday, Johnson warned Britons that the country's rise in cases was "flashing like dashboard warnings in a passenger jet."
Things are no better in India, where the coronavirus case count has passed 7.1 million, a Johns Hopkins tally showed.
More than 109,800 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India's younger and leaner population.
Still, the country's public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.
Meanwhile, Brazil passed 5.1 million cases and had over 150,600 deaths as of Tuesday, the Hopkins tally showed.
Cases are also spiking in Russia: The country's coronavirus case count has passed 1.3 million. As of Tuesday, the reported death toll in Russia was over 22,800, the Hopkins tally showed.
Worldwide, the number of reported infections passed 37.8 million on Tuesday, with nearly 1.1 million deaths, according to the Hopkins tally.
The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.
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