MarkeTouch COVID-19 Clinical and Operations Pharmacy Newsletter (April 15)

by Marketouch BACK TO BLOG.

CDC Advisory Committee on Immunization Practices Recommends Extending the Pause on Administration of Johnson + Johnson Vaccine

On Tuesday (4/13/21), the FDA and the CDC paused the use of Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine at federal sites and have also urged states to halt giving the vaccine. The pause is based on reports of cerebral venous sinus thrombosis in combination with thrombocytopenia. The disorder causes rare and severe blood clots that are occurring among individuals within 2 weeks of receiving the J&J dose. There have been 6 reports of women between the ages of 18 and 48 developing the disorder. So far, 1 woman has died and a second has been hospitalized in critical condition. To date, 7.2 million doses of the J&J vaccine have been administered in the United States.

On Wednesday (4/14/21), the CDC’s Advisory Committee on Immunization Practices (ACIP) met and declined to change or offer additional recommendations regarding the current J&J COVID-19 vaccine pause.  Based on the results of Wednesday’s meeting, no additional Federal government guidance on lifting the pause is forthcoming at this time.

Several ACIP panel members stated the need for more complete evidence to justify voting on the measure, while other panelists cited concerns that a continued indefinite pause would be detrimental to ensuring the country’s equitable vaccine rollout. The ACIP panel did decide to meet in the near future to vote, likely in the next week.

 Vaccine Tracker

According to the CDC, as of 4/13/2021, a total of 245 million doses have been delivered and 192 million doses have been administered. This accounts for; 22.7% of the total population, 29.1% of those over 18 years of age and 62.5% of those over 65 years of age being fully vaccinated.

One in Three COVID-19 Survivors Suffer Neurological or Mental Disorders

One in three COVID-19 survivors, in a retrospective, cohort study of more 230,000 patients, were diagnosed with a neurological or psychiatric outcome within 6 months of infection.  The study found a “robust” link between COVID-19 and a neurological and psychiatric sequelae diagnosis such as dementia, Parkinson’s, stroke and anxiety disorder. The risks were highest among patients who had severe COVID-19, including those who required hospitalization or experienced “delirium and other altered mental states” when they were ill. Additional studies are needed to corroborate and explain initial study findings.

Scruples and Drams

Budesonide – Early treatment with the asthma drug budesonide has been shown in a large study to shorten COVID-19 recovery time in patients older than age 50. 

COVID Long-term Effects – Individuals in a Swedish study reported long-term effects post mild COVID-19.  Of those who had COVID-19 previously, 26% had at least one moderate to severe symptom that lasted more than two months and 11% had a minimum of one symptom that negatively impacted work, social, or home life for at least 8 months.  

Breakthrough COVID – SARS-CoV-2 infection post vaccination is rare, but not entirely unexpected. No COVID-19 vaccine with an FDA EUA is 100% effective at preventing infection. Though the exact number of breakthrough cases to date is unknown, states reporting cases show a 0.01% incidence rate.

Vaccine Updates

Pfizer – Released an updated analysis of their COVID-19 vaccine which found high efficacy and no serious safety concerns for up to 6 months following the second dose.  The vaccine is effective in preventing severe disease:    100% and and 95.3% as defined by the CDC and FDA, respectively. ​It was also reported as 100% effective in preventing cases in South Africa, where the B.1.351 lineage is prevalent.

Moderna – Researchers tested the Moderna vaccine against the Californian variant in a lab and found it to less susceptible but still generated effective protection.

US Army – a vaccine developed by the US Army begins human testing at Walter Reed Army Institute of Research. If effective, the Army likely would seek to join with a drug company to further test and develop the vaccine.

NDV-HXP-S – A new low-cost COVID-19 vaccine, NDV-HXP-S is the first in clinical trials to use an innovative molecular design that could create more potent antibodies compared to existing vaccines.  NDV-HXP-S can be mass-produced in chicken eggs, similar to how influenza vaccines are made.  The initial phase of trials will end in July.

Pediatric COVID-19 Updates

A team of researchers has discovered that blood taken from children before the pandemic had a higher frequency of B cells that could bind to SARS-CoV-2 than adult blood did, even though they had never been exposed to this novel virus.  This research is still in the early stages, but it could go some way to explain why children seem to fare a lot better than adults when it comes to falling ill with COVID-19.

Building Tomorrow’s Mask

To address issues related to face coverings and masks currently available and to accelerate the development of the next generation of masks, the Biomedical Advanced Research and Development Authority and the National Institute for Occupational Safety and Health have partnered to launch the Mask Innovation Challenge.

The Mask Innovation Challenge seeks innovative and effective designs for mass-producible, low-cost-per-use devices to be worn by the general public. Masks should provide protection from respiratory disease pathogens. Users should be able to put them on and wear them without extensive fitting procedures or complicated user instructions.

Cash prizes will be awarded.  Up to ten winners will be eligible to receive up to $10,000 each for the first design phase and up to five winners will be selected to split a total $400,000 prize purse.

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