Moderna’s COVID-19 Vaccine Candidate Gets More Good News

The biotech company Moderna released new data Monday morning that strengthens the case for its COVID-19 vaccine. It concludes the vaccine is 94% effective — and strongly protects against serious illness. Based on these latest findings, the company plans to submit an application for emergency use authorization to the Food and Drug Administration today.

They build on Moderna’s previously reported findings, based on a smaller number of cases detected in its study of about 30,000 volunteers.

Moderna’s COVID-19 Vaccine Shines In Clinical Trial
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Moderna’s COVID-19 Vaccine Shines In Clinical Trial
Overall, the study identified 185 cases in the people who received a placebo shot, compared with 11 cases in people who got the active vaccine. These latest findings are similar to results from Pfizer, which has developed a similar vaccine. And, like the Pfizer vaccine, this one seems to prevent severe cases.

“There were 30 cases on placebo and zero cases that were on the vaccine,” says Dr. Stephen Hoge, the president of Moderna. “So, it looks like in the trial we’ve been 100% effective at preventing severe COVID-19, which is really what’s driving the burden of disease in hospitals and ultimately straining our public health systems.”

Based on those findings — and an analysis of the vaccine’s safety and side effects — Moderna has decided it has enough information to submit an application to the FDA. The agency will consider granting emergency use authorization for the product in the coming weeks.

“They will receive a good stack of paper,” Hoge says, “but they’ve been receiving paper almost continuously from when we started.”

What It Was Like To Participate In The Clinical Trial For Moderna’s COVID-19 Vaccine
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What It Was Like To Participate In The Clinical Trial For Moderna’s COVID-19 Vaccine
Pfizer applied for emergency use authorization on Nov. 9 for its COVID-19 vaccine. The FDA will hold its advisory committee to discuss that application on Dec. 10. That meeting is open to the public.

The FDA’s charge is to assure that drugs are both safe and effective, and the agency says it is not cutting corners when it comes to COVID-19 vaccines, which will potentially be given to many millions of healthy people.

“They still have an important and solemn responsibility to review that data and develop an independent perspective on it,” Hoge says, “and that’s not an easy thing to do on a short time horizon.”

Moderna expects that on Dec. 17, the FDA will be ready for a public meeting to discuss this data. A vaccine could get the thumbs-up shortly thereafter. Either or both the Pfizer and Moderna vaccines may start to become available in mid to late December, though supplies will be limited.

Both use the same novel technology. Instead of injecting a weakened or dead virus, which is a common strategy for vaccines, these products are essentially small pieces of genetic material. When that’s injected into a person’s arm, it’s picked up by cells in the immune system. The cells read the genetic code and use that to produce a protein that is actually a key fragment of the coronavirus. The body then builds antibodies that latch onto that fragment, so if and when someone encounters the actual coronavirus, the body is primed to fight it off with antibodies.

Though the key action is happening at a cellular level, inoculation can trigger noticeable symptoms, ranging from a sore arm to achiness, or even fever and flu-like symptoms.

Dr. Carlos del Rio, a vaccine scientist at Emory University in Atlanta, was involved in testing the Moderna vaccine. The symptoms he saw were quite similar to symptoms people get when they get the shingles vaccine. For many, the shingles vaccine creates a strong reaction.

“You feel terrible for a day or two but then you’re fine,” del Rio says.

That’s the price of getting a vaccine that protects you, in the case of COVID-19, from a potentially deadly disease. But del Rio says it is a complication in administering the vaccine, because people who get these symptoms after a shot might think the vaccine actually gave them COVID-19.

Americans Could See A Vaccine By Mid-December, Says Operation Warp Speed Adviser
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Americans Could See A Vaccine By Mid-December, Says Operation Warp Speed Adviser
“We’re going to have to do very good messaging to explain to people this is not COVID, it’s a side effect of the vaccine and it’s OK to have it,” del Rio says. “It actually means the vaccine is working.”

The vaccine studies have been designed to show whether a shot prevents someone from falling ill. But scientists don’t yet know whether people who are vaccinated can still get infected but remain without symptoms. That’s important because if a vaccine can prevent even silent infections, it can further reduce the spread of the pandemic.

Hoge said the company is collecting data to look for those silent infections among vaccinated volunteers, but that information won’t be in hand until early next year. So, it’s possible that some people who are vaccinated can still spread the virus.

“That’s why I tell people when you get vaccinated, continue wearing your mask,” del Rio says. “We’re going to know later if the vaccine actually prevents infection.”

He says it’s remarkable how quickly all this has come together — less than a year from the time the novel coronavirus was first identified, to now, apparently on the verge of having tens of millions of doses of vaccine ready to go.

“A vaccine that prevents people from getting, sick, especially from getting critically ill? It’s a great vaccine right now,” del Rio says. With nearly 2,000 deaths per day, “My God, we really need this vaccine.”

California Hospitalizations From COVID-19 Surging; ICUs May Be Overwhelmed In Weeks

California hospitals are in a new surge of COVID-19 cases, and if trends continue, state intensive care units could be overwhelmed by Christmas Eve.

The state saw a new daily high for coronavirus cases, reaching 14,034 and an overall total of 1,212,968. An additional 20 deaths were reported for a total of 19,141.

As of Monday, 8,578 people are in California hospitals with COVID-19. Overall, 75% of ICU beds are occupied — and without intervention could reach 112% by Dec. 24, according to projections shared by Gov. Gavin Newsom on Monday.

The state will consider further restrictions over the next two days similar to the shutdown order implemented earlier this year with “modifications,” Newsom said.

Black and Latino residents are being disproportionately affected by the virus and are more likely to die from it, according to the Los Angeles Times. Latinos are almost three times more likely than whites to test positive after adjusting for population.

Current case numbers are likely delayed because some health offices were closed on Thanksgiving. The number of reported cases could rise in the next few days, and the impact of holiday gatherings on infections may not be seen for weeks.

Los Angeles County, the nation’s most populous with 10 million residents, went into another lockdown Monday. Residents are prohibited from gathering with people outside their household for public or private occasions except for political protests and religious services.

“We were prepared for an increase,” said Barbara Ferrer, Los Angeles County public health director, on Saturday, according to the Los Angeles Times. “None of us really thought the increase would be so big across such a short period of time.”

Los Angeles Mayor Eric Garcetti estimated that more than 4,000 residents could die in the next five weeks if the virus’s spread isn’t slowed, the Los Angeles Times reported.

California has classified 51 of the state’s 58 counties as purple, or “widespread,” the state’s highest risk-level assessment. This largely restricts indoor activities, and it closes bars, limits restaurants to outdoor or takeout service and reduces occupancy in retail businesses. Purple counties are also under a curfew.

“We are sounding the alarm,” Newsom said this month. “The spread of COVID-19, if left unchecked, could quickly overwhelm our health care system and lead to catastrophic outcomes.”

Reese Oxner is an intern with NPR’s News Desk.

Why Our Brains Struggle To Make Sense Of COVID-19 Risks

Millions of Americans traveled for Thanksgiving despite pleas not to do so from the Centers for Disease Control and Prevention. Dr. Deborah Birx of the White House Coronavirus Task Force says if you’re one of them, assume you’re infected, get tested and do not go near your friends or family members without a mask on.

Because COVID-19 is a largely invisible threat, our brains struggle to comprehend it as dangerous. Dr. Gaurav Suri, a neuroscientist at San Francisco State University, explains how habits can help make the risks of the virus less abstract.

Emergency room doctor Leane Wen discusses why it’s tempting to make unsafe tradeoffs in day-to-day activities and how to better “budget” our risks.

In participating regions, you’ll also hear a local news segment that will help you make sense of what’s going on in your community.

Email us at considerthis@npr.org.

This episode was produced by Brianna Scott, Art Silverman and Lee Hale. It was edited by Connor Donevan with help from Christopher Intagliata and Wynne Davis. Our executive producer is Cara Tallo.

Dr. Scott Atlas, Special Coronavirus Adviser To Trump Resigns

A controversial coronavirus adviser to the president, Dr. Scott Atlas, resigned Monday, a White House official told NPR.

Atlas, who is not an infectious disease expert and whose brief stint was marred by blunders and controversy, was tapped by the Trump administration to serve as special adviser to the president of the United States, in August. Since then, “the MRI guy” has repeatedly been at odds with the nation’s leading health officials regarding his views on how to combat the spread of the virus, including members of the White House Coronavirus Task Force.

But throughout his tenure, he has insisted all of the guidance he’s offered was based on scientific research.

“I worked hard with a singular focus—to save lives and help Americans through this pandemic,” Atlas wrote in a resignation letter posted to Twitter.

He added that he “always relied on the latest science and evidence, without any political consideration or influence.”

“As time went on, like all scientists and health policy scholars, I learned new information and synthesized the latest data from around the world, all in an effort to provide you with the best information to serve the greater public good,” Atlas wrote.

Fox News reported that Atlas’ role was set to expire at the end of the week.

Stanford University Appears To Distance Itself From Scott Atlas After ‘Rise Up’ Tweet
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Stanford University Appears To Distance Itself From Scott Atlas After ‘Rise Up’ Tweet
Trump was attracted to Atlas’ views, which put the economy first, but public health experts were appalled by his lack of scientific rigor.

Among the theories that most worried experts is Atlas’ belief that allowing the coronavirus to spread would eventually result in “herd immunity,” describing it as a “basic principle” of biology and immunology.

As NPR reported:

“In April on the conservative Steve Deace Show, Atlas spoke in favor of allowing the virus to pass through the younger segments of the population, while trying to protect older Americans.

” ‘We can allow a lot of people to get infected,’ he said. ‘Those who are not at risk to die or have a serious hospital-requiring illness, we should be fine with letting them get infected, generating immunity on their own, and the more immunity in the community, the better we can eradicate the threat of the virus.’ ”

President Trump’s New COVID-19 Adviser Is Making Public Health Experts Nervous
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President Trump’s New COVID-19 Adviser Is Making Public Health Experts Nervous
Atlas’ field of expertise is in magnetic resonance imaging. He wrote a book on the subject and co-authored numerous scientific studies on the economics of medical imaging technology. He was also a professor and chief of neuroradiology at Stanford University Medical Center from 1998 to 2012, according to a university biography.

“He’s an MRI guy … He has no expertise in any of this stuff,” Dr. Ashish Jha, the dean of the Brown University School of Public Health told NPR, referring to the COVID-19 pandemic that has killed nearly 267,000 people in the U.S.

“He’s been bringing out arguments that have been refuted week after week, month after month, since the beginning of this outbreak,” Jha added.

Stanford University Appears To Distance Itself From Scott Atlas After ‘Rise Up’ Tweet
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Stanford University Appears To Distance Itself From Scott Atlas After ‘Rise Up’ Tweet
Atlas also made numerous political blunders during his brief stint, including a lengthy interview with Russian state media that ran just days before the U.S. presidential election.

He later apologized for the misstep saying he “was unaware they are a registered foreign agent.”

“I regret doing the interview and apologize for allowing myself to be taken advantage of,” Atlas said in a tweet. “I especially apologize to the national security community who is working hard to defend us.”

And earlier this month, Stanford University appeared to distance itself from Atlas following his remarks that residents of Michigan should “rise up” against the state’s new coronavirus restrictions.

Atlas took a leave of absence from his position as a senior fellow at the Hoover Institution, a conservative-leaning think tank based at the university, to serve as an adviser to the president.

As recently as late October, Atlas was believed to be among Trump and the Vice President Mike Pence’s closest advisers on the pandemic, Dr. Francis Collins, director of the National Institutes of Health, told NPR.

Atlas has been highly critical of the lockdowns enforced by various state and municipal leaders — a strategy he continued to oppose in his farewell letter.

Since Atlas began his job in August, nearly one hundred thousand people have died of COVID-19 in the U.S.

Atlas did have encouraging words for the incoming Biden Administration.

“I sincerely wish the new team all the best as they guide the nation through these trying, polarized times,” Atlas wrote. “With the emerging treatments and vaccines, I remain highly optimistic that America will thrive once again and overcome the adversity of the pandemic and all that it has entailed.”

NPR’s Geoff Brumfiel contributed to this report.

Some Health Care Workers Are Wary Of Getting COVID-19 Vaccines

Health care workers are expected to be first in line to be offered a COVID-19 vaccine when one is available.

It makes sense: Getting a safe, effective vaccine would help keep them and their patients healthy. Seeing doctors, nurses and medical aides getting COVID-19 vaccines would also set an example for the community.

But the speed of COVID-19 vaccine development, along with concerns about political interference with the process, has left some health care workers on the fence about COVID-19 vaccines.

So many health care workers are expressing concerns and anxiety about getting COVID-19 vaccines that the Centers for Disease Control and Prevention says addressing hesitancy in this group is a top priority. A CDC survey, shared at a public meeting of its vaccine advisory committee on Nov. 23, found that 63% of health care workers polled in recent months said they would get a COVID-19 vaccine.

“I’m really hesitant about it,” says Kida Thompson, a family physician in El Paso, Texas. Her city is in the middle of a huge COVID-19 surge, and she believes that the broad adoption of a safe, effective COVID-19 vaccine will be key to ending the pandemic. But she’s not 100% ready to get one herself. “For the ones of us who are asking questions, there’s just a lot of questions,” she says.

Thompson is a big fan of vaccines in general. “The flu vaccine has been around for a while, its efficacy has been proven, the side effects have been proven, and they are usually minimal,” she says.

But the COVID-19 vaccine is entirely new. Previous vaccines have taken years to develop; this one came together in months.

And the government’s messaging around the vaccine — that it’s the instant solution to the plague of 2020, and that it will be free for everyone — just sounds a little too good to be true, Thompson says. “Fast and free just doesn’t equate,” she says. “This whole thing has been politicized from Day 1, and there’s a salesmanship going into it” that makes her skeptical.

It’s not a population that public health experts initially thought would need much convincing, says Anuj Mehta, a pulmonologist at National Jewish Health in Denver and chair of Colorado’s COVID-19 vaccine allocation committee.

But reports of the Trump administration exerting political pressure on science agencies, along with claims that a COVID-19 vaccine could be available before the Nov. 3 election (it didn’t happen), contributed to concerns that harmful shortcuts might have been taken with COVID-19 vaccines.

Mehta says the fast vaccine development timeline is not, on its own, cause for concern. “The speed is not because people were cutting corners, but because of the urgency and the number of people working together on it,” he says.

Vaccine development processes such as running clinical trials, evaluating data and building manufacturing plants, which typically happen one after another, were instead overlapped. And now that the election has passed, concerns over political interference in the vaccine will likely subside, Mehta says.

Giving COVID-19 vaccines to health care workers is intended to keep them healthy. “We want to be sure our health care workers are safe so they can protect their patients from disease, and that they can be protected and do their work,” says Yvonne Maldonado, a pediatrician at Stanford’s Lucile Packard Children’s Hospital and a vaccine hesitancy researcher.

However, policies pushed earlier in the pandemic seeded doubts among health care workers about whether their health and safety were consistently prioritized. “This is the same population that was told earlier this year that they should just go battle COVID-19 wearing a bandanna or a scarf,” says Michelle Mahon, a registered nurse who represents National Nurses United, a union with more than 150,000 members across the country.

Some health care workers have voiced concerns about safety and potential side effects from COVID-19 vaccines. They want to see clear data on safety and efficacy before they sign on to get a new vaccine, Mahon says.

“It’s a minority of people that are saying absolutely no way [to getting a COVID-19 vaccine],” says Dr. Marci Drees, hospital epidemiologist for ChristianaCare and a liaison to the CDC’s federal vaccine advisory committee. “I think the majority of people really just want to know more.”

Thompson reads medical journals and follows vaccine news closely, and she says a lot of facts just aren’t available yet. “I would legitimately still need convincing,” she says.

But she says she can be swayed. There have been calls by health care experts for the drug companies to release vaccine trial data publicly, and if they do, Thompson says then she’ll be able to judge for herself whether a vaccine is safe. If her friends who are doctors choose to get the vaccine, that could convince her, too.

And, even though Thompson has grown wary of government officials, she does believe in the integrity of at least one top infectious disease expert: Dr. Anthony Fauci, a career scientist who has become known for resisting President Trump’s rosy takes on the pandemic response.

“I trust what [Fauci] says,” she says. “He’s shown that he’s able to actually stand on his own 2 feet during this whole thing without being swayed.”

That’s what Thompson is trying to do, too. She’s going to look at the facts and make up her own mind. Once she’s convinced, she’ll be able to make the case to her patients. She’s already been telling them to wear masks nonstop.

With Trump promising a COVID-19 vaccine ‘very soon,’ industry developers pledge to keep politics out of science

The heads of nine biopharmaceutical companies issued a letter early Tuesday pledging to fully vet their COVID-19 candidate vaccines before asking for federal approval to market them.

“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the statement said.

The statement comes amid increasing concern among public health officials, scientists and doctors that the White House might bring significant political pressure to bear on the Food and Drug Administration to approve a vaccine before the Nov. 3 presidential election.

All nine companies are individually or jointly developing a candidate COVID-19 vaccine supported at least in part with federal dollars, which so far amounts to more than $10 billion. They are AstraZeneca, Johnson & Johnson, Moderna Inc., Novavax Inc., Merck, Sanofi and GlaxoSmithKline, and Pfizer Inc, which is developing a vaccine with BioNTech, another signatory.

A widely used vaccine will be essential to bring the COVID-19 pandemic under control. Industry officials are worried that the political climate is tarnishing the process and will make people more hesitant to get a vaccine when there is one.

The leadership of the industry group Biotechnology Innovation Organization, or BIO, issued a similar statement late last week calling for a testing process “conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects.” The BIO statement also called on the U.S. Food and Drug Administration to “maintain its historic independence as the gold-standard international regulatory body, free from external influence.”

Inside a lab for COVID-19 vaccine study on Aug. 13, 2020, in Hollywood, Florida.

The industry promise to stick to scientific principles and keep politics out of the approval process comes after several weeks in which President Donald Trump repeatedly emphasized that a vaccine probably would be ready for public use before the election.

At a White House news conference Monday, Trump said a vaccine “will be very safe and very effective, and it will be delivered very soon.” He added, “Could even have it during the month of October.”

Trump also has said that if a vaccine was not ready by then, it was because of a “deep state” conspiracy against him.

The fastest vaccine ever developed took four years, although work on a COVID-19 vaccine has been happening at a much faster pace, thanks to advances in technology, research on similar but much smaller coronavirus outbreaks, a concerted effort by the companies, and federal support.

Three of the candidate vaccines are being tested in Phase 3 trials involving 30,000 people each, half of whom will get the active vaccine and half a placebo.

Dr. Stephen Hahn, head of the U.S. Food and Drug Administration, has repeatedly said he would not approve a vaccine until it has been shown to be safe and effective. But he has also said there might be an intermediate endpoint – short of the completion of a 30,000-person trial – that could meet his standards for a so-called emergency use authorization.

The statement from the vaccine developers did not address whether they would consider such an endpoint acceptable, but it did say that they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”

None of the companies would comment Monday beyond what was in the statement.

“This letter appears to be in response to a growing fear in this country that the FDA might not do its job – specifically, to protect Americans from products that are unsafe or ineffective,” said Dr. Paul Offit, a pediatrician and vaccine expert at the University of Pennsylvania. “When we get to the point that we don’t trust the FDA, we’re in trouble.”

Given the statements of coming out of Washington D.C. about vaccines, a letter from pharmaceutical companies pledging to follow the science isn’t surprising, said Art Reingold, head of the epidemiology and biostatistics division at the University of California, Berkeley School of Public Health.

“I would like to think that would always be true, but perhaps the pledge helps reassure some of the many people who are anxious/worried about the vaccine being developed at ‘Warp Speed,’” he said.

Such a statement from industry is unprecedented, said Dr. William Schaffner, an expert in infectious diseases and immunization policy at Vanderbilt University in Nashville.

“I’ve only been doing vaccines for 40 years and I’ve never heard of anything like this before,” he said. “Having the companies themselves issue this statement I think will offer some reassurance. Not completely, but some reassurance to the medical profession.”

Schaffner said he has heard repeated concerns from medical colleagues across the country about Trump and Hahn’s comments, which he said have created “an enormous amount of unease in the very professional people who would be expected to provide strong endorsement of the vaccine, promote it and often give it in their own offices and public health departments.”

Doctors and other medical professionals must be convinced  the vaccine is worthwhile, he said. “If they hold back, that could be an enormous impediment to widespread use of the vaccine.”

Half a million US children have been diagnosed with Covid-19

(CNN)Half a million US children have been diagnosed with Covid-19, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The groups said 70,630 new child cases were reported from August 20 through September 3. This is a 16% increase in child cases over two weeks, bringing up the total to at least 513,415 cases, the groups said in their weekly report on pediatric coronavirus cases.
“These numbers are a chilling reminder of why we need to take this virus seriously,” American Academy of Pediatrics President Dr. Sally Goza said in a news release. “While much remains unknown about COVID-19, we do know that the spread among children reflects what is happening in the broader communities,” she added.
“A disproportionate number of cases are reported in Black and Hispanic children and in places where there is high poverty. We must work harder to address societal inequities that contribute to these disparities.”
Children represent nearly 10% of all reported cases in the US, according to the report. The child cases are likely underreported because the tally relies on state data that is inconsistently collected.
“This rapid rise in positive cases occurred over the summer, and as the weather cools, we know people will spend more time indoors,” Dr. Sean O’Leary, the vice chair of the AAP Committee on Infectious Diseases, said in a news release.
“Now we are heading into flu season. We must take this seriously and implement the public health measures we know can help,” O’Leary added.
“That includes wearing masks, avoiding large crowds, and maintaining social distance. In addition, it will be really important for everyone to get an influenza vaccine this year. These measures will help protect everyone, including children.”
The AAP recommends that any child 6 months or older get a flu shot — in line with recommendations from the US Centers for Disease Control and Prevention.
Pediatricians say it’s more important than ever to make sure kids get either the flu shot or the protective nasal spray before the end of October.
That’s because having two respiratory disease circulating at the same time — flu and coronavirus — will be confusing to doctors, parents and caregivers. Plus, hospitals and clinics could become overwhelmed with the double burden.

The two viruses cause similar symptoms but a study published Tuesday in JAMA Network Open found that children hospitalized with Covid-19 were more likely to have fever, aches, diarrhea and vomiting than were children with influenza.

Children with Covid-19 also tended to be older and have at least one underlying health condition.
Covid-19 and seasonal flu in children lead to similar rates of hospitalization, intensive care admission, and need for a ventilator to help breathing, the study found. The CDC says 188 children died from flu over the 2019-2020 season.

Russia’s Covid-19 vaccine generated an immune response, study says

(CNN)A Covid-19 vaccine developed and tested in Russia generated neutralizing antibodies in dozens of study subjects, and while the vaccine often caused side effects such as fever, those side effects were mostly mild, according to data published Friday in the medical journal The Lancet.

Russia drew criticism when it announced the world’s first approved coronavirus vaccine for public use in August — even before crucial Phase 3 trials had been completed.
In the Phase 1 and 2 studies of the vaccine, which is named Sputnik V, all 76 study participants developed antibodies to the virus that causes Covid-19, according to Friday’s report in The Lancet.
The levels of neutralizing antibody response were similar to the immune response that people had after naturally recovering from Covid-19, according to the study.
A handout photo released by Russian Healthcare ministry (Minzdrav) shows containers with a newly registered vaccine against coronavirus in Moscow, Russia.

The researchers also looked at responses from T cells, another component of the immune system.
“[Outcomes from] the trial also suggest the vaccines also produce a T cell response within 28 days,” the researchers wrote.

Larger trials needed

Scientists not involved in the study said that, while the results are a positive sign, only larger, Phase 3 trials can confirm whether the vaccine actually prevents illness with Covid-19.
“The data on the Russian vaccine studies reported in The Lancet are encouraging,” said Brendan Wren, professor of microbial pathogenesis, London School of Hygiene and Tropical Medicine.
In the study, half of the participants developed fevers and 42% developed headaches. In addition, about 28% experienced weakness and 24% had joint pain.
The article did not say how long these side effects lasted but said “most adverse events were mild.”
The vaccine was registered in Russia in August, before it had gone through large-scale trials. The researchers at the Gamaleya National Research Centre for Epidemiology and Microbiology in Russia received approval on August 26 to do a Phase 3 trial, which is expected to have 40,000 volunteers, according to a press release from The Lancet.
Doctors warn against rushing a Covid-19 vaccine as Fauci says it’s critical to have a safe Labor Day
The researchers are already distributing the vaccine to high-risk groups, according to Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is financing Russian vaccine research.
Gamaleya is using adenoviruses in their Covid-19 vaccines; this is the same approach used in the vaccine developed by the University of Oxford and AstraZeneca. The adenovirus delivers genetic material for the spike protein that sits atop the virus that causes Covid-19, and that genetic material is designed to generate an immune response to the virus.
Adenoviruses can cause a variety of symptoms, including the common cold. The researchers manipulate the virus so it will not replicate and cause illness.
The Gamaleya vaccine is given in two doses, and each dose uses a different adenovirus vector.
“Using two different viruses gives a theoretical advantage,” said Dr. Paul Offit, a vaccinologist at the University of Pennsylvania.
Naor Bar-Zeev, deputy director of the International Vaccine Access Center at Johns Hopkins University, said in a linked comment that the studies are “encouraging but small,” according to The Lancet. Bar-Zeev was not involved in the Russian study, but peer reviewed it.
Dmitriev, CEO of the RDIF, said that the trial results confirm the “high safety and efficacy” of the vaccine, adding in a statement Friday that the results are “a powerful response to skeptics who unreasonably criticized the Russian vaccine.”

Mass trials begin next week

Russia has previously said it plans to begin mass vaccination of citizens in October, and the country’s health ministry has said the country’s frontline medical staff and teachers will be the first vaccinated.
Post-registration trials of the vaccine will begin in Moscow next week, the city’s mayor, Sergey Sobyanin, said Friday.
More than 5,000 people have already signed up to participate in the trials, according to Sobyanin, who spoke during a video conference with Russian President Vladimir Putin.
Here’s why it’s unlikely we’ll have a coronavirus vaccine by Election Day
Sobyanin also announced that he had been vaccinated with the first of the vaccine’s two shots.
The mayor said polls suggest around half of Russian citizens are skeptical about the vaccine.
“According to the polls, around half doubt whether they need to get vaccinated for coronavirus, whether it is developed enough or not. Two months ago, there were almost 90% skeptics,” said Sobyanin.
Without completed Phase 3 trials, Russia has not proven to the world Sputnik V works, though Dmitriev has previously said several countries in Latin America, the Middle East and Asia have expressed interest in procuring the vaccine.
Russia isn’t the only country fast tracking its vaccine — China approved an experimental coronavirus vaccine in June for members of its military, and in August, it emerged the country had been using the vaccine on those in “high risk” professions — such as frontline medical professionals and border inspectors — since July.

Illinois COVID-19: IL reports 1,381 new coronavirus cases, 8 deaths

CHICAGO (WLS) — Illinois public health officials announced 1,381 new cases of COVID-19 Monday along with eight additional deaths.

The total number of COVID-19 cases in Illinois now stands at 250,961 with 8,179 deaths.

The preliminary seven-day positivity rate from August 31 – September 6 is 4.2%.

Within the past 24 hours, the state has processed 28,975 specimens for a total of 4,447,347

As of Sunday night, 1,484 people are hospitalized with COVID-19, with 352 patients in the ICU and 137 patients on ventilators.

The eight additional COVID-19 deaths include:

-Coles County: 1 male 70s
-Cook County: 1 male 50s, 1 male 60s, 1 male 70s

-DuPage County: 1 male 70s
-Jefferson County: 1 male 90s
-LaSalle County: 1 female 80s
-Perry County: 1 female 90s

Health officials concerned about Labor Day weekend gatherings

 

Health officials are warning people to take precautions while getting together with friends and family this Labor Day weekend.

Recent numbers have shown home gatherings including backyard cookouts with family and friends are now a main driver of an increase in COVID 19 numbers.

The CDC posted guidelines for the long weekend, including reminding friends and family to stay home if they are sick, encourage social distancing, host gatherings outdoors if possible, wear masks, wash your hands often, use hand sanitizer and try to limit the number of things you share.

“What we recommend at the beginning of a gathering is to announce the rules. We learn to do these things, we’re gonna stay six feet apart, gonna wear masks and we’re gonna wash our hands before and after a meal and I think there would be some peace if we collectively all kind of have that conversation,” Cook County Chair of Family Medicine, Dr. Mark Loafman said.

9 vaccine makers sign safety pledge in race for Covid-19 vaccine

(CNN)Nine biopharmaceutical companies have signed a joint pledge to uphold “high ethical standards,” suggesting they won’t seek premature government approval for Covid-19 vaccines.

This pledge, released on Tuesday, states: “We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”
The companies that signed the pledge include AstraZeneca, BioNTech, Moderna, Pfizer, Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson and Merck.
The pledge comes at a time when President Trump has repeatedly pushed for a quick vaccine timeline — even referencing Election Day in November.
“[It’s] going to be done in a very short period of time — could even have it during the month of October,” the President said at a press briefing on Monday. “We’ll have the vaccine soon, maybe before a special date. You know what date I’m talking about.”
On August 6, Trump said he was “optimistic” a vaccine would be ready by November 3.
The pledge also comes just about a week after US Food and Drug Administration Commissioner Dr. Stephen Hahn said in an interview with the Financial Times that the agency could consider emergency use authorization or approval for a Covid-19 vaccine before critical Phase 3 trials are complete.
The nine companies on Tuesday wrote that they pledge to “Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”
Pfizer and Moderna have vaccines in late-stage, Phase 3 clinical trials in the United States; Johnson & Johnson is preparing to start one. Vaccine makers are seeking to enroll at least 30,000 volunteers so they can tell whether the vaccine is really safe and protects people from infection.
The vaccine developers involved in the pledge to maintain high ethical standards for vaccines felt the need to reiterate their commitment to high ethical standards and scientific processes, Pfizer CEO Albert Bourla said on NBC’s Today show on Tuesday.
“With increasing public concerns about the processes we are using to develop these vaccines, and even more importantly, the processes that will be used to evaluate these vaccines, we saw it as critical to come out and reiterate our commitment that we will develop our products, our vaccines, using the highest ethical standards and the most scientific [rigorous] processes,” Bourla said.
The nine vaccine makers said they will stand with science, at a time when the world is looking to science — in particular to a vaccine — to help bring us to the end of the pandemic, Bourla said.
“The only rival here is the virus, and the time to get the vaccine to this,” Bourla said.
He called the pledge between nine vaccine makers “historic” and “an unprecedented moment.”