COVID in the Donor Organ: What's the Risk?

 Three U.S. lung transplant recipients contracted COVID-19 from their new organs, including one patient who died and two patients who transmitted the virus to others, researchers found.

From March 2020 to March 2021, nine SARS-CoV-2 infected donors donated organs to 19 recipients. Three individuals who received bilateral lungs acquired infections from the donors but the remaining 16 recipients of extra-pulmonary organs did not, reported Rebecca Free, MD, MPH, of the CDC in Atlanta, and colleagues.

The study looked at 125 cases of potential organ donor-derived infection. All-cause mortality was substantially higher among the 25 recipients with COVID-19 within 45 days of transplant versus the 100 recipients without COVID infections (36% vs 6%).

"These findings suggest a higher risk of donor-derived SARS-CoV-2 infection among lung recipients than recipients of extrapulmonary organs," the authors wrote in Open Forum Infectious Diseases. "While donor-derived SARS-CoV-2 infection is uncommon, it can result in recipient morbidity and mortality."

The first potential SARS-CoV-2 transmission in the U.S. through transplantation was reported in March 2020, the authors stated. In October 2021, the American Society of Transplantation recommended nucleic acid amplification testing (NAAT) of both upper and lower respiratory tract testing in the case of lung donors, and Free and colleagues found that less than half of organ procurement organizations actually obtained donors' lower respiratory tract specimen testing results prior to transplantation.

In the case of the three patients who received donor lungs from a SARS-CoV-2 positive donor, the donor tested negative on a pre-transplant upper respiratory tract specimen, but archived post-transplant lower respiratory tract specimens tested positive.

For their study, the researchers examined data reported to the Organ Procurement and Transplantation Network, including laboratory and epidemiologic assessments, as well as recent solid organ transplant recipient outcomes.

During the study period, about 42,740 organs were transplanted, including 2,736 lungs. Three living donors and 37 deceased donors were referred for investigation of "potential donor-derived SARS-CoV-2 transmission events." While cause of death for deceased donors was determined to be non-infectious, the three living donors had "unknown" SARS-CoV-2 status at the time of transplantation.

Overall, 140 organs from these 40 donors (including 62 kidneys, 33 livers, 22 lungs, 15 hearts, and eight pancreases) were transplanted into 125 recipients. Nine donors had evidence of SARS-CoV-2 infection within 72 hours of organ procurement, the authors said, and nine were not tested prior to organ procurement -- mostly early in the pandemic. They added that in cases where lungs were procured, only 35% of donors had lower respiratory tract testing.

Of the 25 organ recipients who had evidence of COVID infection after transplant, 11 had received a lung transplant, and nine ultimately died (six of the lung recipients). Median time from transplantation to positive test was 7 days. Fourteen recipients with COVID experienced fever, and 15 required mechanical ventilation. Three-quarters were treated with "therapeutic agents" (mostly remdesivir [Veklury], steroids, or convalescent plasma).

Besides the three lung cases of donor-derived infection, one other donor also tested positive for SARS-CoV-2 post-transplant and was linked with two positive recipients who tested positive for SARS-CoV-2 at 7 to 11 days after transplant -- a kidney recipient who experienced symptoms and a liver recipient who was asymptomatic. But "a retrospective serologic test of the donor's serum and a NAAT of lung tissue were SARS-CoV-2 negative, indicating a low probability of donor-derived SARS-CoV-2 infection," the authors noted.

Limitations to the data included that most donors were not tested for SARS-CoV-2 prior to organ procurement during the early stages of the pandemic, that the results are limited by the performance and sensitivity of NAAT tests and specimen types. Finally, "retrospectively identifying the correct source of transmission was challenging," according to the authors.

Disclosures

Free disclosed no relationships with industry. A co-author disclosed support from Merck, Shire, Viracor, Ansun BioPharma, Astellas, Pfizer, and Takeda.

Primary Source

Open Forum Infectious Diseases

Source Reference: Free RJ, et al "Risk of SARS-CoV-2 transmission through solid organ transplantation and outcomes of COVID-19 among recent transplant recipients" Open Forum Infect Dis 2022; DOI: 10.1093/ofid/ofac221.

https://www.medpagetoday.com/transplantation/transplantation/98519

Some Interventions Improve Cognition in Older Adults More Than Others

 Multidomain interventions -- ones that combined cognitive and physical training, for example -- improved cognitive outcomes in older adults with mild cognitive impairment compared with a single intervention, a meta-analysis showed.

Short-term programs composed of two or more interventions led to better global cognition and cognitive domain scores in people with mild cognitive impairment, reported Sarah Fraser, PhD, of University of Ottawa in Canada, and co-authors in JAMA Network Open.

"In this study, nonpharmacological, multidomain interventions mainly focused on physical exercise, cognitive training, mind-body, music, dietary supplements, social engagement, and education were associated with small to medium effect sizes indicating improvements in global cognition, executive function, memory, and verbal fluency," Fraser and colleagues wrote.

"A synergistic association was found, suggesting combined interventions may be superior to single interventions to improve cognitive functioning in older adults with mild cognitive impairment," they added.

In mild cognitive impairment -- an intermediate stage between normal aging and dementia -- people typically demonstrate objective cognitive deficits that don't interfere with daily functioning. People with mild cognitive impairment are at high risk to progress to dementia. However, up to a third of older adults with mild cognitive impairment may revert to normal cognition.

Nonpharmacological interventions like cognitive training can help improve mood and preserve memory. Multidomain interventions have been examined in healthy older adults, but there's been inconclusive evidence to support outcomes in people with mild cognitive impairment, Fraser and co-authors noted.

"Additionally, reviews on this topic have primarily focused on memory or are limited to investigations of cognitive and physical training, while interventions such as mindfulness and nutrition are overlooked," they observed.

In their analysis, the researchers evaluated 28 clinical trials from 2011 through 2021 that included 2,711 people 65 and older with mild cognitive impairment. All trials compared nonpharmacological multidomain interventions with a single active control.

Exposure to the interventions lasted an average of 71.3 minutes for 19.8 weeks, with sessions taking place 2.5 times per week. All interventions lasted less than 1 year.

Multidomain interventions included cognitive components, physical components, nutritional supplements, mind-body components, education, social components, cognitive training with transcranial direct current stimulation, and exercise with music.

Eighteen trials conducted the intervention components sequentially; ten conducted them simultaneously. Interventions were completed in a group setting in 19 studies. In 21 studies, the active control contained one component of the multidomain intervention.

In four cognitive domains, multidomain interventions showed greater effect sizes than single interventions:

• Global cognition: standardized mean difference (SMD) 0.41, 95% CI 0.23-0.59, P<0.001
• Executive function: SMD 0.20, 95% CI 0.04-0.36, P=0.01
• Memory: SMD 0.29, 95% CI 0.14-0.45, P<0.001
• Verbal fluency: SMD 0.30, 95% CI 0.12-0.49, P=0.001

Attention and processing speed did not differ between intervention groups. There were too few studies to pool data about reaction time and visuospatial abilities, Fraser and co-authors noted.

Thirteen studies using the Mini-Mental State Examination (MMSE) demonstrated that the overall pooled effect size favored the multidomain intervention (SMD 0.40, 95% CI 0.17-0.64, P<0.001), showing a greater increase in MMSE scores after the intervention in the multidomain group than the control group.

Scores on other tests -- the category verbal fluency test, Trail Making Test-B, and Wechsler Memory Scale-Logical Memory I and II tests -- also favored the multidomain group.

The review predominantly featured multidomain cognitive-physical interventions, the researchers pointed out. "However, nutrition, mind-body, music, and social interventions also contributed to small-medium effect sizes in global cognition, executive function, memory, and verbal fluency immediately after the intervention," they wrote.

The analysis also had several limitations, Fraser and colleagues acknowledged. Bias may have been introduced if participants were co-recruited for several studies from the same research groups. In addition, the studies lacked sufficient data to account for different cognitive subtypes, like amnestic mild cognitive impairment.

Disclosures

This research was supported by the Canadian Institute of Health Research, the Ontario Ministry of Research and Innovation, the Ontario Neurodegenerative Diseases Research Initiative, the Canadian Consortium on Neurodegeneration in Aging, and the Department of Medicine Program of Experimental Medicine Research Award, University of Western Ontario.

Researchers reported no conflicts of interest.

Primary Source

JAMA Network Open

Source Reference: Salzman T, et al "Associations of multidomain interventions with improvements in cognition in mild cognitive impairment: a systematic review and meta-analysis" JAMA Netw Open 2022; DOI: 10.1001/jamanetworkopen.2022.6744.

https://www.medpagetoday.com/neurology/dementia/98526

Idorsia is first to EU market with orexin insomnia drug

 Idorsia has become the first drugmaker in the EU to claim approval for a drug for chronic insomnia in the dual orexin receptor antagonist class, ahead of rival drugs from Merck & Co and Eisai.

The new drug – Quviviq (daridorexant) – has been approved by the European Commission for adults who have been suffering insomnia for at least three months and are experiencing “considerable impact” on daytime functioning, according to the Swiss pharma company.

Quviviq was approved in the US last year, where it will have to go toe-to-toe in the marketplace with Merck’s Belsomra (suvorexant) and Eisai’s Dayvigo (lemborexant). It was due to be launched in the US yesterday.

The two rivals are approved for insomnia in the US but not in Europe, giving Idorsia first-mover advantage and a chance to make a breakthrough in the region.

The Swiss company reckons Quviviq is less likely to cause residual sleepiness the day after dosing than the rival drugs, because it has a shorter half-life. Both Belsomra and Dayvigo have box warnings on their labels in the US on daytime functioning, including the ability to drive motor vehicles.

Belsomra’s first-to-market advantage in the US hasn’t however translated into big annual sales, which have stayed planted just over the $300 million mark since 2019. Dayvigo, meanwhile, brought in around $86 million for Eisai in the first three quarters of its current fiscal year, so seems to be struggling to gain traction as well.

Some analysts think Quviviq and Dayvigo could take time to get going, but have the potential to reach blockbuster sales levels if their developers can overcome decades of reluctance to prescribe drug therapies for insomnia that stem from their hangover effects and concerns about safety.

The class as a whole is, however, trying to break into a low-cost generic market, and almost inevitably is facing pushback from payers.

According to Idorsia’s chief executive Jean-Paul Clozel, the huge number of people suffering from insomnia means that a new drug only has to have a market penetration of 15% to 20% to reach blockbuster revenues.

“As our first treatment authorised in the EU, the approval of Quviviq marks a significant medical advancement in the management of insomnia and a big milestone for Idorsia,” he said.

A separate application for Quviviq in Great Britain has been filed with the Medicines and Healthcare products Regulatory Agency (MHRA) via the European Commission Decision Reliance Procedure, a post-Brexit, temporary administrative process, under which the MHRA will rely on the decision taken by the EC on the approval of the product.

Also coming through clinical development is another orexin-targeting drug from Johnson & Johnson’s Janssen division – seltorexant – which is in phase 3 testing with results due later this year, albeit only for insomnia associated with depression.

Japan’s Taisho Pharma meanwhile has vornorexant in phase 2 trials as an insomnia therapy.

https://pharmaphorum.com/news/idorsia-is-first-to-eu-market-with-orexin-insomnia-drug/

Fast Track Designation in Hand, Graphite Bio Guns for Definitive Sickle Cell Cure

 San Francisco-based Graphite Bio announced that it has received Fast Track Designation from the U.S. Food and Drug Administration for its investigational therapy GPH101, which is designed to genetically treat sickle cell disease (SCD).

Sickle cell disease has a high unmet need, and since several other companies have recently hit roadblocks with their candidates, the Fast Track Designation is a huge win for both Graphite Bio and patients.

GPH101 is an investigational next-generation gene-edited autologous hematopoietic stem cell (HSC) therapy. Graphite Bio, which specializes in precision gene editing, developed GHP101 to treat sickle cell disease with a two-pronged approach. GHP101 attempts to genetically correct a mutation in the beta-globin gene in order to both decrease production of sickle hemoglobin and restore adult hemoglobin expression. By resolving these two issues, GHP101 could potentially cure the disease.

The treatment received FDA investigational new drug (IND) clearance in December 2020. It also received Orphan Drug Designation. Since then, Graphite Bio has been evaluating the efficacy of GHP101 in clinical trials. Its CEDAR study, a Phase I/II clinical trial, began enrolling patients in November 2021. The endpoints of the study are hemoglobin measurements, gene correction rates, engraftment success and overall safety. Data from the study was presented at the American Society of Hematology (ASH) Annual Meeting & Exposition in December 2021.

Now, with Fast Track Designation, the treatment has hit another milestone.

“This designation has the potential to accelerate the development of GPH101, which we are advancing with the goal of precisely and efficiently correcting the genetic mutation that is the underlying cause of sickle cell disease,” said Josh Lehrer, M.D., CEO of Graphite Bio.

Sickle cell disease is an interesting target for genetic editing companies because it’s the most common monogenic disease (a disease caused by a single genetic mutation). SCD is caused by a single mutation in the beta-globin gene, which causes misshapen red blood cells. This provides a clear target for gene editing companies to test just how effective their treatments are.

The disease affects more than 100 million people worldwide and 100,000 people in the United States alone. The anemia treatment market is expected to surpass $10 billion in 2022, an incentive for companies to invest in the overarching area. Other companies working on sickle cell treatments have had mixed fortunes.

Imara, a Boston-based pharma company, was testing its drug, tovinontrine, in SCD and beta-thalassemia. However, Imara hit a financial rough patch and canceled its tovinontrine programs, along with laying off 83% of its workforce.

Emmaus Life Sciences has had a bit more success. The company is dedicated to treatments for sickle cell disease, and in 2017, its prescription-grade L-glutamine oral powder called Endari was approved by the FDA for SCD. However, Endari can only reduce the acute complications of sickle cell disease – it is not a cure.

For its part, Graphite Bio hopes to continue enrolling patients in the CEDAR Phase I/II trial and expects to have proof-of-concept data available next year.

“The FDA’s decision to grant Fast Track Designation to GPH101 for sickle cell disease signifies the need for novel medicines for this serious genetic disease and supports the ongoing development of our unique gene correction approach that we believe could offer a definitive cure for sickle cell patients,” Lehrer said.  

https://www.biospace.com/article/fast-track-designation-in-hand-graphite-bio-guns-for-definitive-sickle-cell-cure-/

Extradited Scientist Found Guilty of Stealing GSK Secrets

 Two years after Gongda Xue was extradited to the U.S. from Switzerland to stand trial for charges of stealing trade secrets from GlaxoSmithKline, the former scientist has been found guilty in a Philadelphia courtroom.

On Monday, Xue, who worked for Novartis affiliate Friedrich Miescher Institute for Biomedical Research and was a legal resident of Switzerland, was convicted of conspiracy to steal trade secrets, theft and wire fraud, the U.S. Department of Justice announced. Xue was part of a ring of Chinese researchers who were stealing confidential data from western pharma companies like GSK in order to kick start their own companies based in China.

Along with Gongda Xue, the Department of Justice has prosecuted his sister Yu Xue, a former GSK scientist linked to the Chinese startup Renopharma. Both Xue siblings conducted anti-cancer research for their respective companies, and both were illegally stealing data and sharing it with each other in hopes of using that information to support startup companies they both founded.

While Yu Xue was part of the Renopharma team, Gongda Xue had formed his own company, Abba Therapeutics, which was based in Switzerland, where he had been working. The government said both Renopharma and Abba were benefitting from ill-gotten research from both GSK and Novartis. According to the government, Gongda Xue stole FMI research into anti-cancer products and sent that research to his sister, Yu Xue.  She, in turn, took GSK research into anti-cancer products and sent that to Gongda Xue, the government said.

At FMI, Gongda Xue performed basic research for publication in journals. At GSK, Yu Xue performed research relating to that company’s anti-cancer drugs under development. Evidence presented at trial showed the defendant knew that GSK’s research could prove incredibly valuable and that it was proprietary and confidential. 

U.S. Attorney Jennifer Arbittier Williams condemned Xue for the theft of trade secrets.

“The lifeblood of companies like GSK is its intellectual property, and when that property is stolen and transferred to a foreign country, it threatens thousands of American jobs and disincentivizes research and development. Such criminal behavior must be prosecuted to the fullest extent of the law,” Williams said in a statement.

Xue’s conviction follows his sister’s 2018 guilty plea to a conspiracy charge that sent her to prison for eight months. Tao Li, another scientist accused of stealing intellectual property from GSK for Renopharma, also pleaded guilty in 2019. Li was a Renopharma director. Lucy Xi, another former GSK employee, also pleaded guilty to IP theft. Tian Xue, a sister to Gongda and Yu, pleaded guilty to a money-laundering conspiracy for agreeing to launder the financial gains Renopharma expected from developing cancer drugs based on the GSK research.

Yan Mei, another Renopharma director, remains a fugitive in China.

The U.S. government alleges Renopharma was supported by the Chinese government in its efforts to rebrand GSK-developed drugs for its own use. The government’s allegations are based on emails seized from Yu Xue’s computer, where she had identified two Chinese officials who would invest in Renopharma. Renopharma’s own internal projections showed the company could be worth as much as $10 billion based on the stolen GSK data, the Department of Justice said.

For the last several years, the U.S. government has warned of IP theft from agents of the Chinese government.  A 2017 report issued by the FBI noted that intellectual-property theft by China costs the U.S. as much as $600 billion annually.

https://www.biospace.com/article/extradited-scientist-found-guilty-of-stealing-gsk-secrets/

Humacyte’s Engineered Blood Vessels in Final Push Toward BLA

 Humacyte’s engineered blood vessels, human acellular vessels (HAVs), are in a position to take tissue regeneration from a laboratory possibility to a commercial reality. Well into late-stage Phase III trials, the company is making functional blood vessels on a regular basis, for use in repairing or replacing the body’s own damaged vessels. 

These HAVs enable surgeons to restore blood flow with an off-the-shelf conduit that is immediately available. It can be stored for 18 months under normal refrigeration. It also resists infection because it is repopulated with the patient’s own cells. The benefit to patients is significant. 

In contrast, the alternatives are to harvest saphenous vein from the leg, which is not always an option for patients, or to use synthetic materials, such as Teflon or plastics, which tend to cause an inflammatory response in the body. Neither option is universally suitable. 

Humacyte’s initial engineered artery product - the HAV - measures 42cm long and 6mm in diameter. Currently, HAVs are being evaluated in late-stage clinical trials for arteriovenous access for patients with kidney failure who are on dialysis and for patients with vascular trauma from incidents like industrial accidents or gunshot wounds. 

“That size will allow vascular surgeons to repair or replace many of the arteries in the body that need it,” Laura E. Niklason, M.D., Ph.D., Humacyte founder, president and CEO, told BioSpace. That includes, “essentially all the main arteries in the limbs.”

The 6mm HAVs are too large for use in heart bypass surgery, however. “For that, you need a smaller caliber vessel,” she said. Humacyte, therefore, is developing 3.5mm blood vessels for cardiovascular applications. These have advanced to non-human primate studies.

Humacyte’s engineered blood vessels seem to be quite durable. “We have some patients who’ve been using our vessels for dialysis for nine years and counting,” Niklason said. She attributes that durability and functionality to the way in which the vessels are grown, which allows them to repopulate with the patient’s own cells to become a living tissue.

Niklason has been working to engineer blood vessels since the 1990s. Initially, she and her group developed a bioreactor and scaffold system that created the physiologic environment of a blood vessel in the laboratory. “We created the geometry – the tubular shape and the anchoring points – and we also created an environment that had the right biochemical cues to help cells grow and form new blood vessels,” she said.

That included adding the right mechanical cues, too. “We took care to mimic the actions of the heart on the blood vessels that were growing. For example, every time your heart beats, it pumps blood and distends your blood vessels by a couple percent.”

Niklason and her team have also built a large bank of human vascular cells, which they have isolated and qualified. So, by selecting the right cells, and by putting the cells into the engineered culture environment, “those cells execute a program where they are, essentially, generating a new artery,” she said. “Now we can make that happen on a recurring and regular basis.”

Humacyte’s modular, commercial-scale manufacturing units can grow 200 HAVs at a time. “Over eight weeks, the human vascular cells repopulate vessel-shaped scaffolds and form new vascular tissues. Then, the culture medium is drained from the system and replaced with decellularization solutions that wash the donor cells out of the tissue,” Niklason explained.

Consequently, there is no evidence of rejection when the HAVs are implanted into patients. “The patient’s own cells look at the new HAV rather like an empty apartment building. They migrate into the HAV, turning it into a living blood vessel containing vascular cells. It becomes the patient’s own artery over time. This is regenerative medicine in the truest sense – a new artery in a specified location that the patient may not have had before.”

This is possible because scientists have a foundational understanding of how connective tissues such as blood vessels, skin, bone, tendons, etc., heal and regenerate. Less is known about the healing and regeneration of solid organs like the kidney, liver, pancreas, spleen, brain, bone marrow, etc., and some of those solid organs lack good repair processes, Niklason pointed out. Therefore, she believes connective tissues will be the first type of engineered tissue to be commercialized.

Niklason has also been developing tissue regeneration processes since the mid-1990s, when she was a post-doctoral student working in Robert Langer’s laboratory at Massachusetts Institute of Technology (MIT), splitting her time between the lab and Massachusetts General Hospital, where she completed her residency. 

“Even then, in the 1990s, we had a good idea about how blood vessels form, heal and respond to injury,” she said. Coupling known science with an unmet need – “vascular disease is among the biggest killers in Western civilization,” she said – she realized there was a therapeutic imperative to build a company.

She and her post-doc Juliana Blum, Ph.D., and graduate student Shannon Dahl, Ph.D., formed Humacyte to advance the work in 2004. Humacyte’s development program moved into non-human primates in 2009. In 2012, Humacyte moved into human studies. “We have been in humans for more than nine years, with more than 450 patients implanted,” Niklason said. 

While this approach has great potential, “This is fundamentally new technology,” she emphasized. “We’re the first company on the planet to have industrialized and brought to commercial scale this type of human tissue regeneration.” She said Humacyte has the equipment and systems to produce 8,000 blood vessels per year, and the building has space to expand that five-fold.

The challenge now is simply to complete the current Phase III trials and submit a biologics licensing application to the U.S. Food and Drug Administration.

Once approval of the first product happens, the mission will expand. Eventually, Humacyte is considering modifying the engineered vessels for other applications, such as coating them with therapeutic cells. Pancreatic islet cells, which secrete insulin, are one possibility.

https://www.biospace.com/article/humacyte-s-engineered-blood-vessels-in-final-push-toward-bla/

FDA Officials call COVID-19 the 'New Normal' in Op-Ed

 Three long-time U.S. Food and Drug Administration officials, Dr. Peter Marks, M.D., Ph.D., Dr. Janet Woodcock, M.D. and Dr. Robert Califf, M.D., wrote an op-ed in JAMA describing the reality that COVID-19 is unlikely to go away and that it represents “the new normal.”

Marks is the director of the FDA’s Center for Biologics Evaluation and Research; Woodcock is a former commissioner, currently principal deputy commissioner; Califf is currently commissioner.

“It will likely circulate globally for the foreseeable future,” they write, “taking its place alongside other common respiratory viruses such as influenza. And it likely will require similar annual consideration for vaccine composition updates in consultation with the data-driven FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)."

In fact, the FDA and VRBPAC met on April 6 to discuss many of those considerations. They cite significant data, showing that a third dose of the mRNA COVID-19 vaccines from Pfizer-BioNTech and Moderna, provides durable protection against hospitalization and death, yet only 45% of the U.S. population has received the third shot, including only about 68% of people older than 65 years, who are at the greatest risk.

They note that the fourth dose was only recently authorized, so data is not yet available on how protective it is against serious outcomes in the U.S. However, data in Israel suggested it demonstrated additional protection in people 50 years and older.

They state that in addition to needing to determine how many doses and when they should be taken, the actual future composition of the COVID-19 vaccine is under discussion. They write, “To provide maximal benefit across the entire age spectrum, careful consideration will need to be given to the choice of the SARS-CoV-2 variant(s) to cover in the COVID-19 vaccines for the fall and winter of the 2022-2023 season. This is because the variant(s) covered by the vaccine may have an important influence on both the extent and duration of protection against a future SARS-COV-2 variant(s) that may circulate.”

Pfizer noted in its first-quarter financial report Tuesday that it is evaluating its vaccine for emerging variants of concern. Moderna has an ongoing Phase II trial of its bivalent booster shot that combines the Omicron-specific booster candidate with the prototype vaccine.

At the recent meeting of the VRBPAC, the committee mostly agreed that a single vaccine composition used by all manufacturers was desirable and it should be data-driven. They also emphasized the composition should be based “on the totality of the available clinical and epidemiologic evidence, optimally it could be used for both primary vaccination as well as booster administration.”

They hope any such updated COVID-19 vaccine would be available to be dosed with the seasonal influenza vaccine in the Northern Hemisphere starting in about October. They expect a decision will be made in the U.S. by June 2022.

The authors point out, “As plans are being developed for the coming fall and winter, it is critical that patients and caregivers understand the profound benefit of a booster dose of the mRNA vaccines or a second vaccine dose of any kind after the Janssen/Johnson & Johnson vaccine and that this understanding leads to action now in the face of a current uptick in infection rates. Clinicians should not be susceptible to inertia and should continue to recommend that patients get their COVID-19 vaccination status up to date, meaning primary vaccination and relevant booster(s). There is no evidence that getting vaccinated now will have adverse effects or toxicity that would preempt the administration of an additional vaccine dose in the fall months if there is evidence of waning of immunity, a new variant, or an adverse seasonal pattern.”

https://www.biospace.com/article/fda-officials-call-covid-19-the-new-normal-in-op-ed/