COVID Vax Doubled Protection for the Previously Infected

 Unvaccinated adults who were previously infected with COVID-19 were twice as likely to be reinfected as those previously infected but also fully vaccinated, researchers found.

A case-control study in Kentucky found a more than two times higher risk of COVID-19 cases among unvaccinated adults with prior infection compared with their fully vaccinated counterparts (OR 2.34, 95% CI 1.58-3.47), reported Alyson Cavanaugh, PhD, of the CDC, and colleagues, writing in an early edition of the Morbidity and Mortality Weekly Report.

Notably, the data were from May to June 2021, prior to reports of the Delta variant becoming the predominant strain in the U.S.

"This study shows you are twice as likely to get infected again if you are unvaccinated," CDC Director Rochelle Walensky, MD, said in a statement. "Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country."

Cavanaugh's group added that not only does the study suggest that being unvaccinated is associated with a higher likelihood of being reinfected, but "full vaccination is associated with reduced likelihood of reinfection" among those previously infected.

They noted that laboratory evidence suggesting antibody responses following COVID-19 vaccination "provide better neutralization of some circulating variants than does natural infection," but epidemiologic studies among those previously infected have been lacking.

The authors examined a database of Kentucky residents ages 18 or older with positive SARS-CoV-2 infection as confirmed by nucleic amplification testing or antigen testing. They noted that they chose May and June due to vaccine supply and eligibility requirements, adding "this period was more likely to reflect resident choice to be vaccinated, rather than eligibility to receive vaccine."

Case patients were Kentucky residents with a positive SARS-CoV-2 test in 2020 who also had a positive SARS-CoV-2 test in May to June 2021, while controls were those with a positive test in 2020 who were not reinfected during those 2 months in 2021. They were matched 1:2 based on age, sex, and date of positive test result, within 1 week. Vaccination data were from the Kentucky Immunization Registry.

Fully vaccinated individuals received either a single dose of the Johnson & Johnson vaccine or the second dose of the Pfizer-BioNTech or Moderna vaccines at least 14 days prior to reinfection. Partially vaccinated individuals received one dose of mRNA vaccine or received the second dose less than 14 days prior to reinfection.

Overall, there were 246 case patients and 492 controls. About 61% were women, and 83% were previously infected with COVID-19 from October to December 2020. Among case patients, 20.3% were fully vaccinated versus 34% of controls.

While unvaccinated patients with previous infections were twice as likely to be reinfected versus fully vaccinated patients, "partial vaccination was not associated with reinfection," the authors noted (OR 1.56, 95% CI 0.81-3.01).

"If you have had COVID-19 before, please still get vaccinated," Walensky said.

Disclosures

The authors disclosed no conflicts of interest.

Primary Source

Morbidity and Mortality Weekly Report

Source Reference: Cavanaugh AM, et al "Reduced risk of reinfection with SARS-CoV-2 after COVID-19 vaccination -- Kentucky, May–June 2021" MMWR 2021; DOI: 10.15585/mmwr.mm7032e1.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93940

Genesis, biggest U.S. nursing home chain, mandates staff COVID-19 vaccinations

 Genesis HealthCare, the nation’s largest nursing home chain, has declared a “universal” COVID-19 vaccine policy for all employees, care partners and onsite vendors. They have three weeks to come into compliance.

The company made the announcement after the close of trading Monday. It is the biggest shoe to drop in a growing trend toward mandatory vaccinations for long-term care personnel.

Genesis is by far the largest single nursing home company in the country, with 357 facilities and nearly 42,000 skilled nursing beds, according to recent statistics from the American Health Care Association.

The new Genesis policy requires individuals to have a single dose of the Janssen vaccine or the first dose of a two-dose mRNA vaccine by Aug. 23. If applicable, the second mRNA dose would be needed by Sept. 22.

“Our move to adopt universal vaccination is an incredibly important decision, and we very seriously weighed the competing concerns before proceeding down this path,”  said Genesis CEO Harry Wilson in his first public comments since being named the head of the company earlier this year. 

The foremost concern cited by long-term care operators has been that employees set against getting vaccinated would leave their jobs or the profession altogether at a time where staffing shortages are already common. Wilson, however, said there are greater interests in play.

“Despite vaccination rates above the national average, the growing spread of the Delta variant makes clear that we need to increase our vaccination rates substantially to better protect our patients, residents and employees,” he said. “While we would have greatly preferred a strictly voluntary process, our commitment to health and safety outweighs concerns about imposing a requirement. Universal COVID-19 vaccination provides the safest and most effective course of action to ensure the health and welfare of our patients, residents and staff.”

There are two potential valid exemptions for an employee who chooses to decline the COVID-19 vaccine: medical or religious, a Genesis spokeswoman explained. If an exemption is not granted, the unvaccinated employee “may be subject to termination,” she added.

Despite a growing drumbeat for mandatory vaccinations, especially among healthcare workers, the topic has been controversial. AHCA, the nation’s largest nursing home association last week came out in support of providers who may be imposing vaccinations as condition of employment — but it did not outright call for providers to mandate vaccinations.

On the other hand, the nation’s second-largest nursing home association, LeadingAge, was part of a coalition of nearly 60 groups that early last week called for mandatory vaccinations of all healthcare workers. 

Wilson said that a voluntary company vaccination program began in December 2020, emphasizing “communication, engagement and trust-building.” It has netted “above average” conversion rates of 85% for patients and 65% for staff. But more is needed, he said in the company statement.

“Due to age, underlying conditions, or both, nursing home patients and residents are at greater risk of severe illness if they contract COVID-19,” Wilson noted. “This threat can be reduced significantly through universal COVID-19 vaccination.”

The company statement said that it supports AHCA’s “call for ‘all healthcare and long-term care employers to require their employees to be vaccinated against COVID-19 …’ ” An AHCA spokeswoman Tuesday morning, however, confirmed the association’s less stringent stance from last week.

The Genesis statement called making vaccinations a condition of doing business “the logical fulfillment of the ethical commitment of all healthcare workers to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.” Nonprofit long-term care giant Good Samaritan, the fifth-largest nursing home company in the U.S., announced its mandatory vaccination policy July 22.

According to its website, Genesis is a holding company with subsidiaries operating 400 skilled nursing facilities and senior living communities in 26 states. Subsidiaries also supply rehabilitation therapy to approximately 1,200 locations in 46 states and the District of Columbia. Overall, Genesis subsidiaries employ approximately 70,000 people. The website notes that Genesis features skilled nursing, memory care, assisted living and independent living facilities. The company offers cardiac management, onsite dialysis care, mental health and recovery, neurorehabilitation, ventilator care, VA-contracted care, pulmonary and transitional services and more.

https://www.mcknights.com/news/breaking-genesis-biggest-u-s-nursing-home-chain-mandates-staff-covid-19-vaccinations/

COVID: 90% of patients treated with new Israeli drug discharged in 5 days

 Some 93% of 90 coronavirus serious patients treated in several Greek hospitals with a new drug developed by a team at Tel Aviv’s Sourasky Medical Center as part of the Phase II trial of the treatment were discharged in five days or fewer.

The Phase II trial confirmed the results of Phase I, which was conducted in Israel last winter and saw 29 out of 30 patients in moderate to serious condition recover within days.

“The main goal of this study was to verify that the drug is safe,” Prof. Nadir Arber said. “To this day we have not registered any significant side effect in any patient from both groups.”

The trial was conducted in Athens because Israel did not have enough relevant patients. The principal investigator was Greece’s coronavirus commissioner, Prof. Sotiris Tsiodras.

Arber and his team, including Dr. Shiran Shapira, developed the drug based on a molecule that the professor has been studying for 25 years called CD24, which is naturally present in the body.

“It is important to remember that 19 out of 20 COVID-19 patients do not need any therapy,” Arber said. “After a window of five to 12 days, some 5% of the patients start to deteriorate.”

The main cause of the clinical deterioration is an over activation of the immune system, also known as a cytokine storm. In case of COVID-19 patients, the system starts attacking healthy cells in the lungs.

“This is exactly the problem that our drug targets,” he said.

CD24 is a small protein that is anchored to the membrane of the cells and it serves many functions including regulating the mechanism responsible for the cytokine storm.

Arber stressed that their treatment, EXO-CD24, does not affect the immune system as a whole, but only targets this specific mechanism, helping find again its correct balance.

“This is precision medicine,” he said. “We are very happy that we have found a tool to tackle the physiology of the disease.”

“Steroids for example shut down the entire immune system,” he further explained. “We are balancing the part responsible for the cytokine storms using the endogenous mechanism of the body, meaning tools offered by the body itself.”

Arber noted that another breakthrough element of this treatment is its delivery.

“We are employing exosomes, very small vesicles derived from the membrane of the cells which are responsible for the exchange of information between them,” he said.

“By managing to deliver them exactly where they are needed, we avoid many side effects,” he added.

The team is now ready to launch the last phase of the study.

“As promising as the findings of the first phases of a treatment can be, no one can be sure of anything until results are compared to the ones of patients who receive a placebo,” he said.

Some 155 coronavirus patients will take part in the study. Two-thirds of them will be administered the drug, and one-third a placebo.

The study will be conducted in Israel and it might be also carried out in other places if the number of patients in the country will not suffice.

“We hope to complete it by the end of the year,” Arber said.

If the results are confirmed, he vowed that the treatment can be made available relatively quickly and at a low cost.

“In addition, a success could pave the wave to treat many other diseases,” he concluded.

https://www.jpost.com/health-science/covid-90-percent-of-patients-treated-with-new-israeli-drug-discharged-in-5-days-675961

Half of U.S. population fully vaccinated against COVID-19: CDC

 One out of two Americans were fully vaccinated against COVID-19 as of Friday, according to the U.S. Centers for Disease Control and Prevention.

The milestone comes roughly eight months after the United States launched its mass vaccination drive.

The agency said 165,918,256 people, or 50% of the total U.S. population was fully vaccinated, while 182,368,493 people, or 70.6% of the adult population, in the country had received at least one dose.

The United States had administered 349,787,479 doses of COVID-19 vaccines in the country as of Friday morning and distributed 405,102,715 doses.

The CDC tally includes two-dose vaccines from Moderna and Pfizer/BioNTech , as well as Johnson & Johnson's one-shot vaccine as of 6:00 a.m. ET on Friday. 

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Half-of-U-S-population-fully-vaccinated-against-COVID-19-CDC-36096560/

FDA to allow export of certain lots of AstraZeneca COVID vax made at Baltimore plan

 The U.S. Food and Drug Administration said on Friday certain lots of AstraZeneca's COVID-19 vaccine manufactured at a problem-plagued Baltimore facility are fit to be shipped outside the United States.

The plant, owned by Emergent Biosolutions, was producing vaccines for AstraZeneca and Johnson & Johnson but U.S. health regulators in April halted operations following a discovery that J&J's vaccine was contaminated with material used in the AstraZeneca shots.

"The agency conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency," FDA spokesperson Stephanie Caccomo said in a statement.

Late in July, Emergent said it would resume production of J&J's vaccine at the plant following additional reviews and collaboration with the FDA and manufacturing partners.

The two-dose vaccine made in collaboration with the Oxford University is not yet authorized in the United States but has gained regulatory nods in several countries across the globe.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-FDA-to-allow-export-of-certain-lots-of-AstraZeneca-COVID-19-vaccine-made-at-Baltimore-36096987/

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Ocugen-partnered Covaxin submits documents for emergency use in Canada

 While the manufacturers of the Covid-19 vaccine Covaxin have completed their submission to Canadian health authorities for emergency use, they have also stressed that the jab is the only one to have shown efficacy against the Delta variant in a controlled clinical trial.

Covaxin has been developed and manufactured in India by Bharat Biotech, which entered into an agreement with the American firm Ocugen for the North American market, and the latter established a presence in Canada through Vaccigen to facilitate the review process with Health Canada.

Vaccigen applied for emergency use authorisation (EUA) on June 30 and started submission of data and documentation on July 15, a process that was completed on July 20. In a tweet on July 30, Health Canada and the Public Health Agency of Canada confirmed the review was “under way”.

Ken Inchausti, head, investor relations & communications of Pennsylvania-based Ocugen, told the Hindustan Times that while it was not possible to apply a “specific timeline to Health Canada’s review”, they believed that the “Phase 3 data submitted provide a compelling case for the efficacy and safety of Covaxin”.

With Canadian health authorities warning of the portents of a potential fourth wave in the country sparked by the Delta variant, he underscored the relevance of Covaxin in this context. In response to emailed queries, Inchausti said, “With the rapid spread of Covid-19, including its Delta variant, it is clear that additional vaccine options have the potential to help reverse this negative trend. Currently, there are no head-to-head studies between Covaxin and other Covid-19 vaccines. Covaxin is the only investigational Covid-19 vaccine to demonstrate, in a controlled clinical trial, efficacy against the Delta variant. (efficacy rate: 65.2%).”

Ocugen’s Canadian affiliate, the Alberta-headquartered Vaccigen is facilitating regulatory activity in the country. Unlike the USA, where the Food and Drug Administration asked Ocugen to apply for full authorisation, Health Canada has allowed EUA application.

https://www.hindustantimes.com/world-news/covid19-covaxin-submits-documents-for-emergency-use-authorisation-in-canada-101628141571775.html