Disclaimer: this is not an all-encompassing list of news updates from the month of March 2021.
To stay up-to-date with current health updates and ongoings, it is helpful to be informed about events of the immediate past. This news recap discusses a few of the key news releases that were announced during the month of March 2021 that affected the worlds of pharmacy and public health.
The ongoing COVID-19 pandemic is crowding out many other relevant news stories across all industries, and this sentiment also rings true for the healthcare professions. Although there were many exciting announcements about new therapeutics and advancements unrelated to COVID-19 during the month, this discussion has a heavy emphasis on pandemic-related content.
There has been a plethora of news releases that have been announced in March 2021. To summarize, eight of the most relevant stories from the month are described below.
CDC: Vaccinated Individuals Can Gather Without Masks
In early March, the Centers for Disease Control and Prevention (CDC) announced that fully vaccinated individuals can gather indoors without masks. People are considered fully vaccinated 2 weeks after they have received the second dose in a 2-dose series (Pfizer-BioNTech or Moderna) or 2 weeks after they have received a single-dose vaccine from Janssen (Johnson & Johnson), per the CDC.
Specifically, the current guidance states that “fully vaccinated people can: visit with other fully vaccinated people indoors without wearing masks or physical distancing, visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing, [and] refrain from quarantine and testing following a known exposure if asymptomatic.”
After a year of social distancing without exception, this is a considerable step forward.
Although this is a promising step, it is still important to follow all health and safety precautions as recommended by local, state, and federal health authorities.
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$1.9 Trillion Dollar Stimulus Bill Signed into American Law
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After a long period of deliberation by both the United States House of Representatives and the United States Senate, President Biden signed into law a $1.9 trillion ($1,900,000,000,000!) bill, dubbed the ‘American Rescue Plan’, for COVID-19 relief purposes. This is the third and largest stimulus bill signed into American law since the start of the COVID-19 pandemic.
There are many of components of the bill. One of the most popular components has been the $1,400 check to be delivered to every American that makes less than $75,000 of annual income per year. However, there are other components of the bill as well.
Related to the pandemic specifically, the bill also was designed to provide funding for vaccine distribution as well as COVID-19 testing, contact tracing and genomic sequencing. It also is giving money to the Federal Emergency Management Agency (FEMA) as well.
Want to see more information about the stimulus? Consider referencing this stimulus infographic courtesy of Forbes.
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Compiling Evidence that COVID-19 is Disproportionately Affecting Black and Hispanic Communities
Image courtesy of Bebeto Matthews/AP
It has been relatively widely publicized that the COVID-19 pandemic has affected communities of color to a significant degree – this is true. A previous Pharmacist Consult article provides additional commentary on this matter.
Sadly, this is unsurprising. Long-standing systemic health and social inequities have plagued communities of color in this country prior to the current pandemic. Because of this history, it has also created a deadly pathway for this same trend to appear for COVID-19.
According to a report published by the CDC on March 24th, “during April 1–14 [of 2020], 11.4% of counties reported high COVID-19 incidence, including 28.7% and 27.9% of counties with large Asian and Black populations, respectively. During August 5–18, this percentage was 64.7%, including 92.4% and 74.5% of counties with large Black and Hispanic populations, respectively. By December 9–22, 99.1% of counties reported high incidence.”
In other words, as the pandemic worsened, health inequities became more and more apparent. Although this article does not have the solution, it is apparent that these inequities need to be addressed in the near and long-term future.
To make matters worse, communities of color also are experiencing worsened COVID-19 vaccine access compared to other individuals. This is especially the case for Hispanic communities.
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Pfizer-BioNTech and Moderna COVID-19 Vaccines Being Studied in Younger Populations
Image courtesy of Shawn Rocco/Duke Health
As of now, the Pfizer-BioNTech COVID-19 vaccine is approved for use in individuals 16 years of age and older and the Moderna and Janssen (Johnson & Johnson) COVID-19 vaccines are approved for use in individuals 18 years of age and older in the United States.
This begs the question – how can children and teens who are 15 years or younger receive a COVID-19 vaccine? The simple answer is that more data is needed. Once additional safety and efficacy data is gathered for this younger age range, health experts can then assess the data and make a decision on if minimum age requirements can be altered.
Two pieces of good news related to this effort has come out recently.
Moderna announced in mid-March that it is beginning a trial that is enrolling children between the ages of 6 months and 12 years. It is estimated that up to 6,750 healthy children in the United States and Canada will be enrolled in the study. The company was already studying its vaccine in roughly 3,000 adolescents between the ages of 12 and 17 years in a different study. All of these results are yet to be released.
Pfizer also recently announced that its vaccine is safe and effective in children as young as 12 years of age. In Pfizer’s recent study, just over 2,000 U.S. volunteers ages 12 to 15 were studied. In this study, results showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 cases of COVID-19 among those who did not receive the vaccine.
Johnson & Johnson, the parent company of Janssen Pharmaceuticals, also plan to study their COVID-19 vaccine in patients 17 and younger in the near future.
As data continues to be collected and analyzed, more announcements will be released by the manufacturers, CDC, and FDA. Stay tuned.
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Tough Month for the AstraZeneca Public Relations Team
Image courtesy of Mykola Tys/SOPA Images
Over the past month, there have been growing global concerns over whether or not the AstraZeneca COVID-19 vaccine can potentially cause blood clots.
For example, in the United Kingdom, 30 people out of 15.8 million who received at least one dose of the vaccine experienced some type of blood clot. In Germany, this number was 31 cases out of 2.7 million doses. Other countries report similar numbers.
However, even though this is the case, there is an ongoing question being assessed that is trying to determine if the vaccine is truly linked to these blood clotting cases. The evidence is pointing towards not, thankfully, as the European Union (EU) has cleared the vaccine. Regardless, some countries are putting age restrictions on the vaccine and some countries are pausing the use of the vaccine at this time. This is an ongoing situation and more information is to be released.
Separately, AstraZeneca also received criticism in March 2021 for reporting potentially outdated effectiveness numbers from its clinical trial data.
In mid-March, AstraZeneca announced that its vaccine was found to be roughly 79% effective at preventing symptomatic COVID-19 in an American clinical trial of more than roughly 30,000 volunteers. However, a team from the United States-based National Institute for Allergy and Infectious Diseases (NIAID) analyzed the data and deemed that the trial data may be slightly outdated.
This statement from the NIAID raised concern about the numbers being reported. AstraZeneca reanalyzed its trial data within 48 hours and reported that the true effectiveness rate from its American clinical trial was closer to 76% for preventing symptomatic disease rather than 79%. The vaccine is noted to be 100% effective against severe COVID-19.
Regardless of these struggles, it is important to note that the AstraZeneca COVID-19 vaccine is widely used globally and it is still a key contributor toward helping end the COVID-19 pandemic.
It is also important to note that the AstraZeneca COVID-19 vaccine is currently not authorized for use in the United States. The three COVID-19 vaccines currently authorized for use in the United States are from Pfizer-BioNTech, Moderna, and Janssen (Johnson & Johnson).
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Biden Administration’s “90-90” Plan
Image courtesy of the White House COVID-19 Response Team
On March 29th, President Biden unveiled the Biden administration’s “90-90” plan for their ongoing COVID-19 vaccination rollout. Having surpassed the administration’s initial goal of 100 million shots in their first 100 days, the administration has set this new goal.
Specifically, this plan (like the graphic above suggests) highlights that 90% of all adults will be eligible to receive a COVID-19 vaccine by April 19th and that 90% of all Americans will live within 5 miles of a location to receive a shot. The latter part of this statistic is feasible as more and more retail pharmacies are being looped in as critical vaccination sites.
By April 19th, nearly 40,000 pharmacies across the country will be utilized as vaccination sites.
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Development of ‘Vaccine Passports’ – The New Norm?
As businesses of all forms begin to slowly reopen, the success of their reopening plans depends largely on two components – public health precautions and widespread vaccinations.
Regarding widespread vaccinations, proof of vaccination is a phenomenon that will likely become more and more common over the coming months. It is common to give a healthcare provider a copy of your vaccinations when you see them for the first time, but now it will likely become the norm to show a business or other establishment proof of COVID-19 vaccination prior to entering their facilities.
This proof of vaccination, dubbed casually as ‘vaccine passports’, are being developed by numerous software companies and in accordance with many governments across the world, including the United States.
These measures are likely going to be most relevant for travel purposes. It is likely that a “vaccine passport” will need to be shown in some capacity prior to boarding an aircraft or some other form of public transport as the pandemic is slowly beginning to crawl past its peak. This will likely also be the case for sporting events, other forms of entertainment, etc.
In a March 12th White House press briefing, it was stated that the United States government’s central effort in this initiative will be “to help ensure that any solutions in this area [will] be simple, free, open source, accessible to people both digitally and on paper, and designed from the start to protect people’s privacy.”
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FDA Approves Zegalogue (dasiglucagon) for Treatment of Low Blood Sugar
Image courtesy of Zealand Pharma
Although patients with diabetes commonly worry about their blood sugar levels being too high, they also need to be mindful of episodes of hypoglycemia, or low blood sugar. In cases when blood sugar levels get too low, an emergency situation can occur.
On March 22nd, the FDA approved Zegalogue (dasiglucagon) for the treatment of severe hypoglycemia in patients 6 years of age and older. Zegalogue will be sold as an auto-injector and as a prefilled syringe. These dosage forms are quicker and easier to use than old “mix-and-inject” kits that were previously used for the treatment of hypoglycemia.
Zegalogue has a shelf-life of 3 years (36 months) at refrigerated temperatures and it is also stable for up to 1 year (12 months) at room temperature.
Prior to the approval of Zegalogue, other developments have also occurred for the advancement of the treatment of hypoglycemia. Baqsimi, Gvoke HypoPen, and generic glucagon have all been approved by the FDA within the past 2 years and are also viable treatment options that help increase patient access to hypoglycemia treatment(s) when it may be needed.
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