The world’s first “human challenge” trial in which volunteers were deliberately exposed to COVID-19 to advance research into the disease was found to be safe in healthy young adults, leaders of the study said on Wednesday.
The data supports the safety of this model and lays the groundwork for future studies to test new vaccines and medicines against COVID-19 using this kind of trial by the end of this year, the team added.
Open Orphan is running the project, launched last February, with Imperial College London, Britain’s vaccines task force and Orphan’s clinical company hVIVO.
Scientists have used human challenge trials for decades to learn more about diseases such as malaria, flu, typhoid and cholera, and to develop treatments and vaccines against them.
The Imperial trial exposed 36 healthy male and female volunteers aged 18-29 years to the original SARS-CoV-2 strain of the virus and monitored them in a quarantined setting. They will be followed up for 12 months after discharge.
No serious adverse events occurred, and the human challenge study model was shown to be safe and well tolerated in healthy young adults, the company said.
“People in this age group are believed to be major drivers of the pandemic and these studies, which are representative of mild infection, allow detailed investigation of the factors responsible for infection and pandemic spread,” said Chris Chiu, chief investigator on the trial and professor of infectious diseases at Imperial.
The Imperial researchers said they now planned to start a similar study using the Delta variant, and will share their framework around the globe to allow similar research.
That could provide a crucial route to testing new vaccines, antivirals and diagnostics against COVID-19 more quickly, particularly if transmission rates fall in the real world.
Imperial said it could start tests like this using human challenge trials by the end of 2022.
In April, Oxford University launched another human challenge trial which sought to reinfect people to deepen understanding about immunity.
The results of the Imperial study, published on a pre-print server and yet to be peer reviewed, also provide some clinical insights that could inform public health policies.
Researchers found that symptoms start to develop on average about two days after contact with the virus, Imperial said, which is earlier than the widely held view that the virus has an incubation period of around five days.
The infection first appears in the throat; infectious virus peaks about five days into infection, which is also when the most significant symptoms are usually noticed, the researchers said. At that stage, the virus is significantly more abundant in the nose than the throat.
They also found that rapid lateral flow tests were a reliable indicator of whether infectious virus was present and therefore the person was likely to be able to transmit the virus. Most people had live virus in their nose for an average of 6.5 days, they said.
Eighteen volunteers became infected, 16 of whom went on to develop mild-to-moderate cold-like symptoms, including a stuffy or runny nose, sneezing, and a sore throat, Imperial said.
Some experienced headaches, muscle/joint aches, tiredness and fever. None developed serious symptoms.
Thirteen infected volunteers temporarily lost their sense of smell, but this returned within 90 days in all but three participants – the remainder continue to show improvement after three months.
There were no changes seen in their lungs, or any serious adverse events. Only one person had any lingering symptoms by six months – a slightly reduced sense of smell which was improving.
The trial used the lowest dose necessary to infect people, although the team said it was comparable to real-world infections.
The scientists will now study other elements from the trial, including investigating why the 16 of the 34 participants in the final analysis did not get infected despite exposure. Some had detectable virus in their nose but did not go on to test positive twice on PCR tests, the threshold the team used for confirmed infection.
(Reporting by Josephine Mason and Jennifer Rigby; Editing by Andrew Heavens and Alison Williams)
COVID-19 vaccines saved 20M lives in 1st year, scientists say – CTV News
Nearly 20 million lives were saved by COVID-19 vaccines during their first year, but even more deaths could have been prevented if international targets for the shots had been reached, researchers reported Thursday.
On Dec. 8, 2020, a retired shop clerk in England received the first shot in what would become a global vaccination campaign. Over the next 12 months, more than 4.3 billion people around the world lined up for the vaccines.
The effort, though marred by persisting inequities, prevented deaths on an unimaginable scale, said Oliver Watson of Imperial College London, who led the new modelling study.
“Catastrophic would be the first word that comes to mind,” Watson said of the outcome if vaccines hadn’t been available to fight the coronavirus. The findings “quantify just how much worse the pandemic could have been if we did not have these vaccines.”
The researchers used data from 185 countries to estimate that vaccines prevented 4.2 million COVID-19 deaths in India, 1.9 million in the United States, 1 million in Brazil, 631,000 in France and 507,000 in the United Kingdom.
An additional 600,000 deaths would have been prevented if the World Health Organization target of 40% vaccination coverage by the end of 2021 had been met, according to the study published Thursday in the journal Lancet Infectious Diseases.
The main finding — 19.8 million COVID-19 deaths were prevented — is based on estimates of how many more deaths than usual occurred during the time period. Using only reported COVID-19 deaths, the same model yielded 14.4 million deaths averted by vaccines.
The London scientists excluded China because of uncertainty around the pandemic’s effect on deaths there and its huge population.
The study has other limitations. The researchers did not include how the virus might have mutated differently in the absence of vaccines. And they did not factor in how lockdowns or mask wearing might have changed if vaccines weren’t available.
Another modelling group used a different approach to estimate that 16.3 million COVID-19 deaths were averted by vaccines. That work, by the Institute for Health Metrics and Evaluation in Seattle, has not been published.
In the real world, people wear masks more often when cases are surging, said the institute’s Ali Mokdad, and 2021’s Delta wave without vaccines would have prompted a major policy response.
“We may disagree on the number as scientists, but we all agree that COVID vaccines saved lots of lives,” Mokdad said.
The findings underscore both the achievements and the shortcomings of the vaccination campaign, said Adam Finn of Bristol Medical School in England, who like Mokdad was not involved in the study.
“Although we did pretty well this time — we saved millions and millions of lives — we could have done better and we should do better in the future,” Finn said.
Funding came from several groups including the WHO; the U.K. Medical Research Council; Gavi, the Vaccine Alliance; and the Bill and Melinda Gates Foundation.
AP health and science reporter Havovi Todd contributed
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content
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ACIP Backs Moderna's COVID Shot for Kids 6-17 Years – Medpage Today
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Thursday to recommend that children ages 6-17 years receive Moderna’s COVID-19 vaccine.
With a 15-0 vote, ACIP endorsed a two-dose primary series of the mRNA vaccine for kids ages 6-11 years (50 mcg per dose) and adolescents ages 12-17 (100 mcg per dose). The recommendation now awaits approval from CDC Director Rochelle Walensky, MD, MPH.
The recommendation was largely expected, and followed FDA’s emergency use authorization last week. Until then, only Pfizer/BioNTech’s mRNA vaccine had been authorized and recommended for these age groups.
At Thursday’s meeting, ACIP members considered safety and efficacy data on Moderna’s vaccine, which was primarily studied during periods where the ancestral SARS-CoV-2 and Delta strains were predominant, in teens and the younger kids, respectively. In both groups, the vaccine was effective against severe disease and hospitalization.
“We know that the benefits outweigh the risks for mRNA COVID-19 vaccine in all ages,” said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, during the meeting. “Receipt of this primary series continues to be the safest way to prevent serious COVID-19.”
Oliver emphasized that serious outcomes with COVID-19 do not spare kids. The Omicron wave was accompanied by a surge in hospitalizations among children, and she pointed to 189 COVID-related deaths in kids 5-11 years and 443 in kids 12-17 throughout the course of the pandemic.
Several ACIP members raised questions about the intervals between the first and second dose of the Moderna vaccine, as such an approach may reduce the risk of myocarditis associated with the vaccine. Some evidence suggests the Moderna vaccine carries a higher risk of myocarditis or pericarditis than Pfizer’s vaccine, though CDC experts cautioned that these findings are not consistent in all U.S. monitoring systems.
Among close to 55 million doses of Pfizer’s vaccine administered to individuals ages 5-17 years, the rare adverse event has been observed in at least 635 children, according to the CDC. Risk is typically higher among children ages 12-17, in boys, and after the second dose. Among kids age 5-11, there were no signals detected.
In a presentation on clinical considerations, Elisha Hall, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, said that although the current recommendation is for a 4-week gap between the first and second doses, the CDC will likely be recommending an 8-week interval for adolescent males. (The CDC also recommends shorter dose intervals for children who are immunocompromised.)
Some of the ACIP members expressed confusion about the product labels on Moderna’s vaccines in each age group. The product authorized for kids 6-11 will have the same color cap as the vaccine for children ages 6 months to 5 years, but a different color border to distinguish the higher concentration. For the product authorized for kids ages 12-17, it will have the same label as the adult vaccine, as it is the same dose.
“I am … concerned about vaccine administration errors,” said Matthew Daley, MD, chair of ACIP’s working group. Others echoed concerns about administration blunders, encouraging more resources for providers and further clarification on labeling from the manufacturer.
Safety and efficacy data for Moderna’s vaccine in this younger population came from two ongoing phase II/III clinical trials (study mRNA-1273-P203 for adolescents ages 12-17 and study mRNA-1273-P204 for kids ages 6-11 years). The studies included nearly 8,000 kids in total.
Among participants ages 12-17, vaccine efficacy was 93.3% (95% CI 47.9-99.9) during a time when the ancestral and Alpha strains were predominant. Among the younger group, vaccine efficacy was 76.8% (95% CI -37.3 to 96.6) during a period when Delta was most prevalent.
The committee agreed on the data that COVID-19 vaccines protect children against severe disease. Many children in this age group, however, remain unvaccinated. Approximately 30% of teens and 65% of younger kids have yet to receive a vaccine, according to Oliver.
“We can predict with future COVID-19 surges, the unvaccinated will continue to bear the burden of disease,” she said.
COVID Rates Dropping; Vaccination Campaign Continues – ckdr.net
Health officials in Canada are warning of a seventh wave of COVID-19 this fall, with a possible new variant.
Dr. Kit Young Hoon is the Medical Officer of Health for the Northwestern Health Unit and stresses they will be ready.
“Although the timing of an increase in COVID-19 specifically is difficult to predict, the Northwestern Health Unit will be prepared to offer large-scale COVID-19 vaccinations in the fall to protect our communities most vulnerable.”
She notes the vaccine remains the best way to stay protected and vaccines continue to be offered for those eligible.
The Health Unit is reporting 132 COVID cases confirmed through PCR testing.
One hundred of them are in communities under the jurisdiction of the Sioux Lookout First Nations Health Authority.
Medical Officer of Health Dr. Kit Young Hoon says numbers are lower elsewhere.
“Overall, there’s been a steady decrease in hospitalizations due to COVID-19 locally. Case numbers in most health hubs are low, as are our institutional outbreak numbers”.
The positivity rate is sitting at 11.2%.
Case count (Health Hubs):
-Sioux Lookout (on reserve): 100
-Sioux Lookout: (off reserve): 5
-Red Lake: 3
-Fort Frances: 3
There are 3 institutional COVID outbreaks in the region.
That includes one at the Pinecrest home for the aged in Kenora.
Recent testing showed 25 residents testing positive for the virus.
Day and overnight absences have been placed on hold for the time being, but one essential caregiver is allowed for each resident.
Meantime, the Northwestern Health Health Unit says it’s important to continue to get booster doses for COVID-19 vaccinations.
Dr. Kit Young Hoon says there is evidence that the first or second dose starts to drop.
“The vaccine protection does wane somewhere around the six month mark, maybe a little bit earlier or a little bit later, depending on the individual,” says Dr. Young Hoon.
“So its important to have some sense what’s going on, with respect to vaccination policy, and know when you might be eligible in the future for your next dose.”
She adds vaccination criteria hasn’t changed that much over the past few months.
“If its been more than three month since you had COVID then you should be looking to book an appointment for your booster dose. There is added benefit from and protection from a booster dose so you have significantly reduced risk of severe illness and decreased risk from being infected.”
Dr. Young Hoon expects fourth dose eligibility will decrease from 60 years of age and older over the next few months, and the vaccine for kids under the age of five should be available later this summer.
For information on vaccinations, visit Northwestern Health Unit
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