MarkeTouch COVID-19 Clinical and Operations Pharmacy Newsletter (April 2)

According to the CDC, as of 3/30/2021, COVID-19 Vaccine Tracker, a total of 189 million doses have been delivered, 147 million doses have been administered. This accounts for 20.7% of the U.S. population over 18 years of age being fully vaccinated and 49.8% of the U.S. population over 65 years of age being fully vaccinated. Interesting stat: the highest daily reported total number of new daily COVID-19 cases in the U. S. occurred on January 8, 2021 - 315,119. On March 29, 2021 that number was reported as 60,699 new cases. mRNA Vaccines Highly Effective in Real World Situations Nearly 4,000 health care personnel, first responders, and other essential and frontline workers completed weekly SARS-CoV-2 testing for 13 consecutive weeks (HEROES-RECOVER Study). Under real-world conditions, mRNA vaccine (Pfizer and Moderna) effectiveness after full immunization (≥14 days after second dose) was 90% against SARS-CoV-2 infections whether symptomatic or not.  Vaccine effectiveness of partial immunization (≥14 days after first dose but before second dose) was 80%. The results reinforce CDC’s recommendation of receiving full 2-dose immunizations for mRNA vaccines and COVID-19 vaccination is recommended for all eligible persons. Scruples and Drams - News and Notes from around Pharmacy and Healthcare Pfizer announced plans to develop other vaccines beyond COVID-19 using mRNA technology.By April 19, Americans will have access to COVID-19 vaccine in 40,000 pharmacies using the Federal Retail Pharmacy Program, up from the prior 17,000 included pharmacies.Retired pharmacists are among those approved to vaccinate against COVID-19 as the Public Readiness and Emergency Preparedness Act (PREP Act) has expanded its list of the people who can administer the vaccines. Reports from the White House suggest that there is no federal mandate for rolling out COVID vaccine passport systems, leaving the matter to the private sector.46% of individuals who are open to getting a COVID-19 vaccination do not have a preference which one they get (Kaiser Family Foundation) Vaccine Updates Johnson + Johnson is back on track to meeting their 20 million vaccine dose delivery goal by the end of March. Pfizer has begun testing it’s COVID-19 vaccine in children 12 and under. Results from the clinical trial are expected in the second half of the year. The company plans to request emergency use authorization for 12 to 15 year-olds in the coming weeks. AstraZeneca  released high-level results from their Phase III trial. Vaccine efficacy at preventing symptomatic COVID-19 was 76%, 15+ days after receiving two doses, four weeks apart. Vaccine efficacy for participants 65+ was 85%. Results demonstrated 100% efficacy for preventing severe/critical disease and hospitalization. Vaccine Hesitancy - Fewer people are saying they want to “wait and see” how the vaccine works in others before getting it themselves. 17% responded "wait and see" in the KFF March survey, dropping from 22% in February and 31% in January. Patient Care Corner - COVID-19 Vaccine Guidance for People Living with MS The MS Society has released guidance for receiving COVID-19 vaccinations for patients with Multiple Sclerosis. The MS Society reiterated that there is no preferred vaccine, the vaccines are safe to use with MS medications and that people with MS should be vaccinated.   Specific guidance to a patient's disease modifying therapy (DMT): Continue a DMT unless advised by your MS healthcare provider to stop or delay it.Some DMTs may make the vaccine less effective but it will still provide some protection.For those taking Kesimpta, Lemtrada, Ocrevus, or Rituxan consider coordinating the timing of your vaccine with the timing of your DMT dose.Work with a MS healthcare provider to determine the best schedule.Review the MS Society full  considerations related to the timing MS medications with COVID-19 vaccines. Pregnant Women Show Robust Immune Response to COVID Vaccines, Pass Antibodies to Newborns In the largest study of its kind to date, researchers have found the new mRNA COVID-19 vaccines (Pfizer/BioNTech and Moderna) to be highly effective in producing antibodies against the SARS-CoV-2 virus in pregnant and lactating women. The results also demonstrated the vaccines confer protective immunity to newborns through breastmilk and the placenta. Researchers also compared vaccination induced antibody levels to those induced by natural COVID-19 infection during pregnancy, and found significantly higher levels of antibodies from vaccination. Lastly, vaccine-generated antibodies were also present in all umbilical cord blood and breastmilk samples taken from the study, showing the transfer of antibodies from mothers to newborns.
April 2, 2021

MarkeTouch COVID-19 Clinical and Operations Pharmacy Newsletter (March 3)

Janssen COVID-19 Vaccine Receives EUA The FDA has issued emergency use authorization (EUA) for the Janssen (Johnson + Johnson) COVID-19 vaccine.  The single dose (0.5 ml) injection is authorized use in individuals 18 years of age and up.  The most commonly reported side effects were; pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and appeared within 1-2 days, lasting the same 1-2 day timeframe.   Storage of unpunctured multi-dose vials is at 2°C to 8°C (36°F to 46°F). The vaccine should be protected from light. Do not freeze the Janssen COVID-19 vaccine. Unpunctured vials of Janssen COVID-19 vaccine may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours. After the first dose has been withdrawn from a vial, that vial can be kept between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (25°C / 77°F) for up to 2 hours. Discard the vial if the vaccine is not used within these times. Vaccine Updates Johnson + Johnson - A CDC epidemiologist said Monday that in the rare case where patients experience an allergic reaction to the first dose of either the Pfizer or Moderna (mRNA) vaccine they could use the Janssen vaccine, at least 28 days later, under the advise and supervision of their doctor.  CDC guidance above. Novavax - A vaccine from Novavax could be available in the U.S. as early as May, according to their CEO, if the FDA allows data from a U.K. phase 3 trial that showed the shot had 89% efficacy.  A phase 3 trial that includes 30,000 U.S. participants is ongoing.  Moderna - has developed a booster COVID-19 vaccine that specifically targets the South Africa variant.  Phase 1 clinical trials will begin soon. Pfizer - FDA agreed to allow the Pfizer-BioNTech vaccine to be transported and stored for up to two weeks at conventional temperatures typically found in pharmaceutical freezers. Should I Still Wear a Mask After Covid-19 Vaccination? Both the Pfizer-BioNTech and Moderna vaccine do not provide significant first dose immune protection until 12 - 14 days after the first dose and they only reach 51 - 52% efficacy after a few weeks, per a December study in The New England Journal of Medicine. During this antibody building period, the body is still relatively vulnerable to COVID-19 infection.  People will also need to be thoughtful of if and when friends and family get vaccinated until researchers are sure about the risk of COVID-19 transmission post vaccination, and a large enough portion of the population is vaccinated to achieve herd immunity. Therefore, it is the widely held recommendation that we must continue to wear masks, practice social distancing and maintain good hygiene. CDC guidance is coming soon on safe activities for those who have received a full course of a COVID-19 vaccine.
March 4, 2021

MarkeTouch COVID-19 Clinical and Operations Pharmacy Newsletter (February 11)

How Does the Johnson & Johnson COVID-19 Vaccine Work? While each of the Pfizer, Moderna and Johnson & Johnson vaccines target the spike protein found on the surface of SARS-CoV-2, the Johnson and Johnson vaccine, manufactured by Janssen, uses a completely different technology.  The Janssen vaccine is what’s called an adenovirus-vectored vaccine.  The adenovirus acts as a sort of Trojan horse to deliver SARS-CoV-2 protein to the immune system. It cannot replicate or cause disease. Once injected, the adenovirus goes inside your cells and releases that SARS sequence. Your body then converts it into the spike proteins of SARS-CoV-2, minus the disease-causing virus. Then, your immune system learns to recognize the spike protein. Allowing your immune system to provide a faster, stronger defense next time it encounters the COVID-19 causing virus. Vaccine Updates Johnson & Johnson - the FDA set February 24th as the date, for the committee to review the Janssen, single dose, COVID-19 vaccine.  They are expected to make a decision about an emergency use authorization (EUA) shortly after the meeting. Pfizer - on February 7th, Pfizer shared that it has doubled its output in the last month and will soon be able to cut the time it takes to produce a batch of vaccines from 110 days to 60 days on average.  AstraZeneca -  expects to have a modified version of its COVID-19 vaccine that will be effective against the South Africa variant by fall. AstraZeneca stated that the modified version would require less time and less clinical testing than the original. Moderna - is asking U.S. regulators to allow it to increase the amount of coronavirus vaccine put into each vial by as much as 50%, which they state can accelerate patient vaccine access.  An FDA decision could take several weeks. Vaccinated Mothers May Pass on SARS-CoV-2 Antibodies to Newborns Pregnant women are of the designated high-risk groups requiring special protection from COVID-19.  Researchers have been trying to determine if vaccinating pregnant women would produce protective antibodies that are capable of crossing the placenta reaching the fetus or newborn. A newly released study describes the first case of anti-SARS-CoV-2 antibodies detected in the cord blood of an infant born to a mother immunized with the first dose of the Moderna vaccine three weeks earlier. Data shows that detectable levels of IgG antibodies to the SARS-CoV-2 virus were found in the cord blood sample. While further research is needed, protection for babies of vaccinated moms may be possible. Ford Designs Clear Mask to Aid Hearing-Impaired Ford has developed, designed and is preparing to market a patent-pending, clear respirator in the hopes of benefitting those with hearing impairments. What makes the respirator mask unique is that it is transparent, low-cost and reusable.  The goal is to permit people to communicate better by seeing the full range of human expression.  For individuals with a hearing impairment, the clear mask would allow them to improve lip reading ability currently hidden by currently available personal protective equipment. Ford expects the respirator to certify to N95 standards of virus protection. Effectiveness testing is currently ongoing.  Ford is hoping to make the product available later this spring. Do You Have a Solution in Place, Capable of Handling Massive COVID-19 Immunization Requests? Enter MarkeTouch's Health and Wellness Scheduler.  Currently managing millions of COVID-19 vaccine appointment inquires daily, the Health and Wellness Scheduler has been enhanced to allow pharmacies the ability to customize appointment availability.  It also offers customizable mobile-optimized vaccine consent forms either as a stand alone service or incorporated into the patient appointment scheduling process. Contact MarkeTouch today to learn more about adding the convenience of appointment scheduling to your COVID-19 vaccination strategy.
February 11, 2021

About Salient

The Castle
Unit 345
2500 Castle Dr
Manhattan, NY

T: +216 (0)40 3629 4753

All rights reserved Salient.