COVID-19 Update Week of May 24, 2021

Prepared by: Toni P. BrownChief Administrative OfficerDelaware River Port AuthorityMay 23, 2021

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In this Week’s COVID-19 DeckFocus: Confusion about CDC’s Recent Guidance on Masking

COVID-19 Virus Tracker

Infections and Deaths

167 millionConfirmed COVID-19 Cases Worldwide

2.07%Rate of COVID-19-Related Deaths Worldwide

3.46 millionCOVID-19-Related Deaths Worldwide

5Data is approximate as of 5/23/2021

33.1 millionConfirmed COVID-19 Cases in the U.S.

1.77%Rate of COVID-19-Related Deaths in the U.S.

589,000 (an increase of ‘just’ 4,000)COVID-19-Related Deaths in the U.S.

6 Data is approximate as of 5/23/2021

1.01 million Confirmed COVID-19 Cases in the NJ

2.60%Rate of COVID-19-Related Deaths in the NJ

26,072COVID-19-Related Deaths in the NJ

7 Data is approximate as of 5/23/2021

1.20 millionConfirmed COVID-19 Cases in the PA

2.25%Rate of COVID-19-Related Deaths in the PA

27,079COVID-19-Related Deaths in the PA

8 Data is approximate as of 5/23/2021

Vaccines

Status of EUAs Granted

COVID-19 Vaccines Granted Emergency Use Authorization (EUA) by U.S. Food and Drug Administration (FDA)

▸ United States of America

▹ EUA granted 12/11/2020

■ Pfizer-BioNTech

■ 16 years and older

■ FDA authorizes vaccine for adolescents 12-15 years old

■ mRNA vaccine

▹ EUA granted 12/17/2020

■ Moderna (in partnership with NIAID)

■ 18 years and older

■ mRNA vaccine10

FDA Authorizes Pfizer Coronavirus Vaccine for Adolescents 12 to 15 Years Old

▸ FDA says:

■ Two-shot regimen is safe and effective for younger adolescents

■ In a news briefing, FDA officials said the Pfizer authorization for 12- to 15-year-olds was a straightforward decision because the data showed that the vaccine was safe and that the response to the vaccine was even better than among the 18- to 25-year-olds who got the shots

■ Children rarely suffer serious bouts of COVID-19. But there is no way to predict the few who will become dangerously sick or develop a rare, dangerous inflammatory syndrome. Out of more than 581,000 covid-19 deaths in the United States, about 300 have been people under 18 — a tiny fraction of the total.

■ But that exceeds the number of children who die in a bad flu season.

■ Children appear to be less efficient at spreading the virus, although their role in transmission is still not fully understood — another reason for pediatric vaccinations.

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FDA Authorizes Pfizer Coronavirus Vaccine for Adolescents 12 to 15 Years Old

▸ Pfizer says:

■ The agency based its authorization on a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom received the same two-shot regimen shown effective and safe in adults.

■ Within each age category, a separate risk-benefit assessment may take place. In the youngest children, given the low risk from the coronavirus, side effects may figure more prominently into the analysis.

■ Researchers may end up choosing a lower dose of vaccine. The understanding of children’s role in transmission may also evolve and help guide vaccine use and public policy.

■ Pfizer representative: “We are proceeding carefully, cautiously.”

■ Pfizer: “We’re using the same rigid guidelines we use in all vaccines, and we take this very seriously. I think as time goes on and more information becomes available, some of the questions may be easier to address.”

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FDA Authorizes Pfizer Coronavirus Vaccine for Adolescents 12 to 15 Years Old

▸ Pfizer says:

■ William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said data from tests in children as young as 2 years old may be available by September or October, with data on children as young as 6 months possible by the end of the year.

■ The agency based its authorization on a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom received the same two-shot regimen shown effective and safe in adults.

■ The expansion of eligibility to children will probably ignite debates in families about when to get vaccinated, and among policymakers about whether it should be required.

■ Dorit Reiss, a law professor focused on vaccine policy at the University of California Hastings College of Law, said she thinks it is unlikely children will be mandated to receive a coronavirus shot until the vaccines win full approval and not just emergency use authorization.

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ModernaTrials with Adolescents and Younger Children

▸ Per Moderna:

■ Moderna recently announced that an initial analysis of its teen trial found its vaccine was 96 percent effective among participants who received at least one dose.

■ Moderna is in discussions with regulators about the data.

■ Pfizer-BioNTech and Moderna are testing their vaccines in children as young as infants. Johnson & Johnson is planning pediatric trials of its single-shot vaccine.

■ Trials in younger children are expected to take longer, because researchers must step down gradually in age and determine a safe and effective dose. Researchers took blood samples and measured antibody levels triggered by the shots and found stronger immune responses in the teens than those found in young adults. There were 16 cases of covid-19 in the trial, all of them among adolescents who received a placebo, suggesting the regimen offered similar protection to younger recipients as it does to adults.

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Emergency Use Authorization (EUA) by FDA

▸ United States of America

▹ EUA granted 2/27/2021

■ Janssen (Johnson & Johnson)

■ 18 years and older

■ Adenoviral vector vaccine READ: NYTimes - An excellent primer on adenovirus vector vaccines

■ FORBES: Everything You Need To Know About Johnson & Johnson’s COVID-19 Vaccine

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Oxford-AstraZeneca’s VaccineStatus: In the Pipeline

▸ Oxford University and AstraZeneca (AZD1222)

▹ Viral Vector Vaccine

▹ A specially engineered virus delivers genetic instructions to human cells to make the spike protein jutting out from the new coronavirus’s surface.

▹ AstraZeneca pledged the vaccine would cost just a few dollars per dose and be sold without making a profit. ($4.00 per dose)

▹ Compare to Pfizer’s vaccine costs per dose: $18.40 - $19.50.

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Oxford-AstraZeneca’s VaccineStatus: In the Pipeline

▸ Oxford University and AstraZeneca (AZD1222)

▹ Data from clinical trial in the United States, Chile and Peru

■ Trials included 32,449 adult participants in all age groups, most of them in the United States

■ The volunteers received two standard doses of the Oxford-AstraZeneca vaccine, or a placebo, at a four-week interval

■ Scientists said the data shows that the vaccine is 79% effective against symptomatic COVID-19, and 100% effective against severe illness

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Vaccine Distribution & Administration Progress to Date - as of May 23, 2021

Approximately 39.2% of the total U.S. population– or 130,014,175 million people --

is now fully vaccinated. Today, 49.2% - approximately 163,309,414 of the population

have had at least one dose.

Vaccine Tracker – United StatesAs of May 23, 2021 - Based on Data from the Centers for Disease Control and Prevention

Overall US COVID-19 Vaccine Distribution and Administration

• 357,250,375 million doses have been delivered

• 285,720,586 million doses have been administered

• Number of people fully vaccinated: 123,282,685 (up by 6,731,490 people)

• Pfizer-BioNTech administered– 154,119,424

• Moderna administered – 121,125,577

• Janssen (Johnson & Johnson) administered – 10,265,423 (increase of 611,392)

• Not identified – 201,162

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U.S. Leads in Number of People Who Have Had at Least One Dose

▪ Sixty percent of Americans have had at least one dose, President Biden said Monday, May 17.

That's in stark contrast to the population around the globe. To increase the world supply, Biden

announced the United States will distribute at least 80 million doses of vaccines

abroad over the next six weeks, which would make the U.S. the world leader in sharing

vaccines.

▪Of the many countries where need for vaccines is great, India stands out. Thousands are dying of

COVID-19 there each day. Meanwhile, over the past six weeks, the rate of vaccination in

India has halved from 4.2 million doses daily to 2 million. For a country with a record of

large vaccine drives, this is a major stumble at a critical time.

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CDC Eases Mask-Wearing Guidance for Fully Vaccinated People

Leads to ConfusionLinks to Articles of Interest

Medical professionals were caught off guard, as were members of the Biden administration, elected

officials and business leaders. Here's how swiftly the CDC advanced those mask recommendations:

Director Rochelle Walensky approved an update to mask guidance last Monday. President Biden

was briefed Thursday morning, May 13. The guidance became public later that day.

CDC Guidance on Mask WearingConfusion/Concerns – ‘It caught us off guard’

▪ Americans are processing how this change affects their work and habits. Baristas, restaurateurs and other

workers responded with emotions as diverse as worry and relief in interviews with Post reporters.

Confusion was a common refrain, too. “It’s been like that from the beginning,” said a chef in Minneapolis.

“One minute it’s this, the next minute it’s that. … You get tons of conflicting messages, and then all of

the sudden one day without notice, no more mask.”

▪Without a systematic way to discern who is vaccinated and who is not, the honor system is

fundamental to these recommendations. As top federal infectious-disease expert Anthony S. Fauci

told CNN last week, “You’re going to be depending on people being honest enough to say whether they are

vaccinated or not." But, reporter Marisa Iati notes, Americans don't always have faith in their fellows to do

what's right.

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CDC Guidance on Mask Wearing"Turning on a dime and stopping wearing masks, even if I'm fully vaccinated, just feels very sudden.“ (Angie Kamel)

▪ NPR - As more states shed their universal mask mandates for those who are vaccinated, many Americans are weighing

how much faith to put in the new guidance from the Centers for Disease Control and Prevention and in the integrity of

their unvaccinated peers, who are supposed to follow the rules and keep wearing masks.

▪ NPR 3-Minute Listen: Even With The No-Mask Guidance, Some Pockets of the U.S. aren't Ready to Let Go

▪ Dr. Fauci said in a new interview that some Americans do not have a full understanding of the latest guidelines put

forth by the federal government relative to mask wearing and coronavirus vaccines. "I think people are

misinterpreting, thinking that this is a removal of a mask mandate for everyone. It's not.” "It's an assurance to

those who are vaccinated that they can feel safe, be they outdoors or indoors."

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Articles of Interest

▸ CDC Condemned by National Nurses United for Updated Guidance

▸ CDC Director Says Mask Turnaround Based Solely on Science - But, she added, even though the guidance has changed, “there’s no need for everybody to start ripping off their masks. There is no mandate to take it off. What we’re saying is, now this is safe. Work at your own speed, work with your own family and your own businesses to remove them when necessary.”

▸ COVID-19 Variants Cause Concern as New Cases Emerge

▸ Dr. Fauci: Booster Shots May Depend on Variants

▸ Pandemic Meets Epidemic: Obesity and COVID-19

▸ How the COVID pandemic ends and when: Scientists look to the past to see the future

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Articles of Interest

▸ USA TODAY: Opinion: The Backstory: Vaccinated readers tell us they still plan on wearing masks. Why? They don't trust others.

▸ What The New Mask Guidance Means For Unvaccinated Kids — And Their Parents

▸ Med Page Today Op-Ed: What Was CDC Thinking With Its New Mask Guidance? — The agency has lurched from over-caution to abandoning all caution

▸ Schools Are Dropping Mask Requirements, But A New CDC Study Suggests They Shouldn't

▸ NJ To Resume In-Person Jury Trials on or after June 15, as Virus Trends Improve

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ThanksQuestions or suggestions for future updates?

You can find me at:

tpbrown@drpa.org

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