A study has begun to assess the antibody response to an additional dose of a COVID-19 mRNA vaccine in kidney and liver transplant recipients, either alone or with a concurrent reduction in immunosuppressive medication. The clinical trial will enroll people for whom two to four doses of a COVID-19 mRNA vaccine did not elicit a detectable antibody response. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the Phase 2 trial, called COVID Protection After Transplant–Immunosuppression Reduction, or CPAT-ISR.
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Monday, January 31, 2022
Everyone has their pandemic pastime. What’s Francine Ricchi’s? Tracking the lengths of COVID testing lines.
By the end of May 2020, all states in the US have eased their COVID-19 mitigation measures. Different states adopted markedly different policies and timing for reopening. An important question remains in how the relaxation of mitigation measures is related to the number of casualties. To address this question, we compare the actual data to a hypothetical case in which the mitigation measures are left intact using a projection of the data from before mitigation measures were eased. We find that different states have shown significant differences between the actual number of deaths and the projected figures within the present model. We relate these differences to the states different policies and reopening schedules. Our study provides a gauge for the effectiveness of the approaches by different state governments and can serve as a guide for implementing best policies in the future. According to the Pearson correlation coefficients we obtained, the face mask mandate has the strongest correlation with the death count than any other policies we considered.
Last week, Julia Ma did something the majority of people in the United States can't – she got an authorized second COVID-19 booster shot after one dose of Johnson & Johnson's vaccine.
Ma's J&J shot was followed five months later by a Pfizer-BioNTech booster dose. Her third shot, another Pfizer, put her on par with 86 million Americans who’ve had three doses of either the Pfizer or Moderna COVID-19 vaccine, as a two-dose series plus a booster.
Only J&J recipients who are immunocompromised are authorized by the federal government to get a single initial shot and two boosters.
But this month the San Francisco Department of Public Health sanctioned a second booster dose for everyone who got J&J as their first shot, making it the only known place in America where a third shot is officially allowed for those with normal immune protection.
Ma, 37, said because she’s fully vaccinated she’s not terribly worried about COVID-19, but she’s hoping to travel next month and wanted to make sure she wouldn’t be a vector for others while omicron surged.
“I don't want my vax status to be a barrier to that," she said. "I opted for the J&J initially because I liked that it was only one shot, but I sometimes feel like the CDC guidelines forget about J&J recipients.”
An accommodation for J&J recipients
San Francisco's Department of Health described the third dose as “an accommodation” based on recent studies that found a third dose of an mRNA COVID-19 vaccine, such as from Pfizer and Moderna, is needed to induce adequate protection as immunity wanes. The third dose reduces symptomatic infection, hospitalization and severe outcomes from the omicron variant.
The second booster is only available to residents of San Francisco or people who got their initial J&J vaccination there.
"San Francisco’s Department of Public Health has always been a vanguard of the way things should be from a scientific perspective," said Dr. Peter Chin-Hong, a professor of medicine and infectious disease at the University of California, San Francisco.
In a release, the department said while the research so far has focused on people whose vaccines were either from Pfizer or Moderna, “We believe that similar studies in persons whose primary series was a single J&J vaccine dose would yield similar results showing that three doses are needed for optimal protection.”
Such studies are not available in part because so few people have gotten the J&J vaccine. In the United States, 119 million people have been fully vaccinated with Pfizer, 74 million with Moderna and 16 million with J&J, said Chin-Hong.
“While there’s understandable frustration with the absence of data, I’m not a fan of the decision to wing it ahead of data,” said Dr. Kelly Moore, chief executive officer of Immunize.org, which educates health care professionals about U.S. vaccine recommendations
A mix and match vaccine study published last week in the New England Journal of Medicine found the highest levels of antibodies for J&J recipients were produced when it was followed by an mRNA vaccine.
“If you get as your second dose of either Moderna or Pfizer, you’re going to get much higher antibody levels and we have a good sense that higher antibody levels are advantageous,” said Dr. William Schaffner, a professor and infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee.
For people who got either Pfizer or Moderna, a booster is recommended five months after the last dose of their original two-dose series. Multiple studies show for people who got an mRNA vaccine, three doses of vaccine were much more protective against getting omicron than two.
A Yale study of 37,877 people in Connecticut who got PCR COVID-19 tests between Dec. 12 and 26 found those who’d gotten two mRNA doses five months ago had omicron positivity rates of 4.2% while people who’d had a third (booster) shot had positivity rates of 2.2%.
The J&J vaccine is still highly protective against severe COVID-19 disease and death, which has always been the goal of all three vaccines.
A study of 20 J&J recipients by researchers at Harvard who developed the one-shot vaccine found people from different parts of the world who received it were protected against severe disease regardless of the virus variant.
In a statement, Johnson & Johnson said "A growing body of evidence demonstrates that our vaccine provides protection when administered as a single dose for an efficient response to the pandemic and as a booster dose at least two months after primary vaccination to protect against symptomatic COVID-19."
COVID questions?: Your coronavirus resource guide
The company points to a South African study conducted while the omicron variant was dominant there that found one J&J shot followed by a J&J booster was 85% effective against COVID-19 related hospitalization.
Dr. Anthony Fauci. a top health adviser to President Biden, has said that while there’s much more data available on Pfizer and Moderna vaccines, the protection provided by J&J plus one booster appears to be parallel.
“I do think Johnson & Johnson is right that two doses are going to be good to avoid severe outcomes," said Dr. Sten Vermund, dean of the Yale School of Public Health.
But while an initial dose plus a boost is good, it still doesn’t answer the question of optimizing dosing, he said.
“If I were a J&J recipient, I would welcome a two-dose mRNA booster, which would be a grand total of three doses,” he said.
Should J&J have been two doses?
Many scientists think J&J should have been a two-dose vaccine from the beginning, which would make its booster the third in the series, just like the mRNA vaccines.
Scientifically it makes sense, said Chin-Hong. Multiple vaccines against other diseases fit into this category, priming and then reminding the immune system.
“Measles, mumps, rubella, hepatitis B, the human papillomavirus, it’s always a similar formula," he said. "You have a one-two vaccination punch, you wait a while and then you remind the immune system.”
The CDC could authorize a third J&J shot if it chose to, but the question hasn't been brought to its Advisory Committee on Immunization Practices said Schaffner, who sits on the committee.
"An additional dose, a third dose for the initial J&J recipients, has not been proposed as a near-team discussion for that group," he said.
Some J&J recipients have managed workarounds, said Chin-Hong. “I’ve spoken to parents with college-aged kids who’ve gotten a J&J shot in another state, and then when they came home they got an additional shot,” he said.
Other workarounds may be inadvertently on the horizon.
Selena Burke lives in Hilton Head, South Carolina. She got the J&J vaccine as her first shot, followed by a Pfizer booster Oct. 27. She’d like to get another booster next month, when she’s five months out, but can’t because it’s not currently allowed
But soon, pharmacists in her state might not be able to ask if she’s been previously vaccinated. A proposed law there would make it a criminal offense for any public, private or nonprofit entity to ask anyone their vaccination status, with possible fines up to $14,000 or a year’s jail time.
“Then maybe I could get the second Pfizer shot,” Burke said.
Meridian Bioscience Inc. on Monday said it received an award from the National Institute of Health Rapid Acceleration of Diagnostics initiative to help research, develop and produce the company's Revogene molecular viral respiratory diagnostic testing panel.
Meridian said the Revogene respiratory panel will simultaneously detect SARS-CoV-2, respiratory synovial virus, and influenza A/B infections.
Meridian said the $2.5 million in additional funding follows an original $5.5 million award. The funding is provided as part of an NIH initiative to speed technologies for Covid-19 testing, the company said.