FDA Experts Are Still Puzzled Over Who Should Get Which Covid Shots and When

At a meeting to simplify the nation’s covid vaccination policy, the FDA’s panel of experts could agree on only one thing: Information is woefully lacking about how often different groups of Americans need to be vaccinated. That data gap has contributed to widespread skepticism, undervaccination, and ultimately unnecessary deaths from covid-19.

The committee voted unanimously Thursday to support the FDA’s proposal for all vaccine-makers to adopt the same strain of the virus when making changes in their vaccines, and suggested they might meet in May or June to select a strain for the vaccines that would be rolled out this fall.

However, the panel members disagreed with the FDA’s proposal that everyone get at least one shot a year, saying more information was needed to make such a declaration. Several panelists noted that in recent studies, only about a third of people hospitalized with a positive covid test actually were there because of covid illness. That’s because everyone entering a hospital is tested for covid, so deaths of patients with incidental infections are counted as covid deaths even when it isn’t the cause.

The experts questioned the rationale for annual shots for everyone, given that current vaccines do not seem to protect against infection for more than a few months. Yet even a single booster seems to prevent death and hospitalization in most people, except for the very old and people with certain medical conditions.

“We need the CDC to tell us exactly who is getting hospitalized and dying of this virus — the ages, vulnerability, the type of immune compromise, and whether they were treated with antivirals. And we need immunological data to indicate who’s at risk,” said Dr. Paul Offit, director of the Vaccine Education Center and a pediatrician at Children’s Hospital of Philadelphia. “Only then can we decide who gets vaccinated with what and when.”

Offit and others have expressed frustration over the lack of clear government messaging on what the public can expect from covid vaccines. While regular boosters might be important for keeping the elderly and medically frail out of the hospital, he said, the annual boosters suggested by the FDA and the drug companies may not be necessary for everyone.

Read the full article from KHN.

Omicron-targeted COVID-19 boosters now authorized for children ages 6 months and older

OLYMPIA  – The Washington State Department of Health (DOH) and other healthcare providers will soon begin offering omicron variant-targeted bivalent booster doses of COVID-19 vaccines to children ages 6 months and older. This follows guidance and recommendations from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

  • Children 6 months through 5 years of age who received the original (monovalent) two-dose Moderna COVID-19 vaccine series are now eligible to receive a booster of the updated (bivalent) Moderna COVID-19 vaccine two months after their last dose.
  • Children 6 months through 4 years of age who have not started or completed their three-dose Pfizer-BioNTech COVID-19 vaccine series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 vaccine.
  • Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 vaccine are not eligible for an updated (bivalent) booster dose at this time.

DOH urges all parents and guardians of children ages 6 months and older to prioritize vaccinating their children with the updated booster if eligible, or starting the COVID-19 vaccine primary series if they are yet to begin. Washington state is currently seeing record pediatric hospitalizations from respiratory viruses and vaccines add an extra level of protection from severe illness. Additionally, flu vaccines are available to everyone 6 months and older at provider offices and pharmacies across the state. Flu and COVID-19 vaccines can be safely given at the same time.

“This is great news that infants and young children can now get the updated bivalent booster, which offers better protection against Omicron subvariants,” said Tao Sheng Kwan-Gett, MD, MPH, Chief Science Officer. “We encourage everyone 6 months and older to get up to date on your COVID-19 vaccines and boosters as well as the seasonal flu shot in order to keep yourself and those around you safe, and to reduce the pressure on our severely stressed hospital system.”

Pediatric-focused COVID-19 boosters are expected to start arriving in provider offices the week of December 12. To make a vaccine or booster appointment, visit VaccinateWA.org, or call the COVID-19 Information Hotline at 833-VAX-HELP. Language assistance is available. If you have questions, visit DOH’s COVID-19 Vaccine Frequently Asked Questions webpage or talk to a trusted healthcare provider.

COVID-19 Cases and Deaths, Vaccinations, and Treatments by Race/Ethnicity as of Fall 2022

As the United States enters its third holiday season navigating a potential increase in COVID-19 cases as well as other respiratory illnesses, federal data from the Centers for Disease Control and Prevention (CDC) show that as of November 9, 2022, 80% of the total population in the United States have received at least one dose of a COVID-19 vaccine and only 10% of eligible individuals have received the updated, bivalent booster that was authorized for use among individuals 5 years of age and older in early Fall 2022. Individuals who have not received any booster dose are at higher risk of infection from the virus, and people who remain unvaccinated continue to be at particularly high risk for severe illness and death.

Over the course of the pandemic, racial disparities in cases and deaths have widened and narrowed. However, overall, Black, Hispanic, and American Indian and Alaska Native (AIAN) people have borne the heaviest health impacts of the pandemic, particularly when adjusting data to account for differences in age by race and ethnicity. While Black and Hispanic people were less likely than their White counterparts to receive a vaccine during the initial phases of the vaccination rollout, these disparities have narrowed over time and reversed for Hispanic people. Despite this progress, a vaccination gap persists for Black people. COVID-19 outpatient treatments, which can mitigate hospitalization and death from COVID-19, are also available. However, early data suggest racial disparities in access to and receipt of these treatments.

This data note presents an update on the status of COVID-19 cases and deaths, vaccinations, and treatments by race/ethnicity as of Fall 2022, based on federal data reported by the Centers for Disease Control and Prevention (CDC).

What is the status of COVID-19 cases and deaths by race/ethnicity?

Racial disparities in COVID-19 cases and deaths have widened and narrowed over the course of the pandemic, but when data are adjusted to account for differences in age by race/ethnicity, they show that AIAN, Black, and Hispanic people have had higher rates of infection and death than White people over most of the course of the pandemic. Early in the pandemic, there were large racial disparities in COVID-19 cases. Disparities narrowed when overall infection rates fell. However, during the surge associated with the Omicron variant in Winter 2022, disparities in cases once again widened with Hispanic (4,341 per 100,000), AIAN (3,818 per 100,000), Black (2,937 per 100,000), and Asian (2,755 per 100,000) people having higher age-adjusted infection rates than White people (2,693 per 100,000) as of January 2022 (Figure 1). Following that surge, infection rates fell in Spring 2022 and disparities have once again narrowed. However, as of September 2022, the age-adjusted COVID-19 infection rates were still highest for Black and Hispanic people (192 per 100,000 for each group), followed by AIAN people at 188 per 100,000. White and Asian people had the lowest infection rates at 164 per 100,000 and 153 per 100,000, respectively. While death rates for most groups of color were substantially higher compared with White people early on in the pandemic, since late Summer 2020, there have been some periods when death rates for White people have been higher than or similar to some groups of color. However, age-adjusted data show that AIAN, Black, and Hispanic people have had higher rates of death compared with White people over most of the pandemic and particularly during surges. For example, as of January 2022, amid the Omicron surge, age-adjusted death rates were higher for Black (37.4 per 100,000), AIAN (34.7 per 100,000), and Hispanic people (29.9 per 100,000) compared with White people (23.5 per 100,000) (Figure 1). Following that surge, disparities narrowed when death rates fell. As of August 2022, age-adjusted death rates were similar for AIAN (4.9 per 100,000), Black (4.4 per 100,000), and White people (4.2 per 100,000) and lower for Hispanic (3.6 per 100,000) and Asian (2.7 per 100,000) people. Despite these fluctuations over time, total cumulative age-adjusted data continue to show that Black, Hispanic, and AIAN people have been at higher risk for COVID-19 cases, hospitalizations, and deaths compared with White people.

Read the full article from KFF here.

Updated COVID-19 booster eligibility expanded to people ages 5 and older

The Washington State Department of Health (DOH) and other healthcare providers will soon begin offering Omicron variant-targeted bivalent booster doses of COVID-19 vaccines to people ages 5 and older, following guidance and recommendations from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Western States Scientific Safety Review Workgroup.

“This is another step forward to a healthier tomorrow for everyone in Washington state,” said Umair A. Shah, MD, MPH, Secretary of Health. “The more people who are eligible for COVID-19 boosters, the better protection we can provide to our communities.

This new demographic of booster eligibility expansion follows last month’s rollout of the updated (bivalent) COVID-19 vaccine, which specifically targets the BA.4 and BA.5 subvariants that currently make up the majority of COVID-19 cases across the country. The Department of Health urges all individuals 5 and older to prioritize receiving the updated booster as we enter the beginning of cold and flu season. Additionally, flu vaccines are now available at many provider offices and pharmacies across the state and are safe to receive concurrently with the COVID-19 bivalent booster.

“It’s also time to get your flu shot,” Dr. Shah added. “We are entering respiratory illness seasons and it is a critical time to protect yourself and those around you from influenza.”

DOH’s updated COVID-19 booster dose recommendations are as follows:

  • People ages 5 and older who have completed a primary vaccine can receive the Pfizer-BioNTech bivalent booster at least two months after their most recent dose. These doses are scheduled to begin arriving in provider offices the week of October 17th.
  • People ages 6 and older who have completed a primary vaccine series can receive the Moderna bivalent booster at least two months after their most recent dose. Providers who already have an inventory of Moderna can begin administering these doses immediately.
  • Children ages 6 months to 4 years remain eligible for the primary, monovalent COVID-19 vaccine series from both Pfizer-BioNTech and Moderna and are not currently authorized for any COVID-19 booster doses.

As with previous vaccine and booster rollouts, the CDC will provide states with weekly allocations, building each state’s inventory levels over time. DOH urges the public to remain patient as we expect initial demand to exceed availability, resolving in the following weeks.

To make a vaccine or booster appointment, visit VaccinateWA.org, or call the COVID-19 Information Hotline at 833-VAX-HELP. Language assistance is available. Those individuals with further questions are encouraged to visit DOH’s COVID-19 Vaccine Frequently Asked Questions webpage or talk to their trusted healthcare provider.

Public health experts recommend the flu and COVID-19 vaccines for everyone age 6 months and older

The Washington State Department of Health (DOH) is urging the public to get an influenza (flu) vaccine in addition to a COVID-19 booster this fall to keep themselves and others safe and out of the hospital.

In recent years flu activity was low due to the preventive benefits of social distancing, masking, and other COVID-19 precautions. Now that guidance and recommendations have relaxed, people are more active, mobile, and have returned to traditional gatherings. At the tail of the last flu season, Washington experienced an unusual late spring wave of flu.

With the start of fall, many adults have returned to in-person work and most children are back in school. These conditions could lead to an increase in flu or COVID-19 cases this fall or winter.

“Flu can be unpredictable and sometimes severe,” said Tao Sheng Kwan-Gett, MD, MPH, Chief Science Officer. “To protect your family’s health, getting vaccinated against influenza with a flu shot or nasal spray vaccine should be part of the fall routine for everyone 6 months and older. It’s also the perfect time to get up to date on COVID-19 vaccines and boosters too.”

Young children, pregnant people, those with underlying health conditions, and people aged 65 and older are at high risk for flu-related complications. The flu is a highly contagious disease that can cause severe illness and lead to hospitalization and death – even in healthy, young people. Getting a flu vaccine reduces the chance of flu illness and protects individuals from serious flu symptoms. The flu shot can be safely given at the same time as a COVID-19 vaccine or booster.

Flu illness is more dangerous than the common cold for children, especially for children under 5 years old. Flu can be deadly in young children. About 80% of flu-related deaths in children are in those who were not vaccinated. Across Washington, the flu vaccine, and all recommended childhood vaccines, are available at no cost for everyone age 18 years and younger.

For weekly flu activity reports, educational materials, vaccine information, and other flu prevention resources, visit www.KnockOutFlu.org. For more information on COVID-19 vaccines, visit the COVID-19 website.

COVID-19 Boosters

The CDC recently recommended the following updated mRNA COVID-19 vaccine boosters to help restore protection that has waned since previous vaccination and target more transmissible and immune-evading variants:

  • The Moderna bivalent mRNA COVID-19 booster is authorized for people 18 and older.
  • The Pfizer bivalent mRNA COVID-19 booster is authorized for people 12 years and up.

These boosters are referred to as “bivalent” vaccines because they target both the original strain of COVID-19 and the Omicron BA.4 and BA.5 subvariants currently circulating in the United States. These updated boosters will help better protect us against these and future variants that might be closely related to Omicron.

Everyone who is eligible to receive the bivalent booster – including those who are moderately and severely immunocompromised – are recommended to receive ONE dose of the booster regardless of how many doses they have received previously. Those eligible may receive the updated booster if at least 2 months have passed since their last COVID-19 dose (either the final primary series dose or the last booster).

The original (monovalent) mRNA COVID-19 vaccine boosters are no longer authorized for people aged 12 years and older and can no longer be given to them, even if they had not previously received a monovalent booster dose. Children ages 5-11 should still receive the monovalent booster (at least 5 months after their second dose).

Routine Childhood Immunizations, Seasonal Influenza, & COVID-19 Vaccination can be co-administered

COVID-19 disrupted both in-person learning and routine well-child visits for many children. As a result, tens of thousands of children and adolescents have fallen behind on receiving recommended vaccines.

Timely vaccination is critical, as immunization schedules are designed to provide children with immunity early in life before they may be exposed to life-threatening diseases. Not only do delayed or missed vaccines leave children vulnerable to illness but when vaccination rates fall even just a little, vaccine-preventable diseases can spread easily.

We know from studies conducted throughout the pandemic that receiving a COVID-19 vaccine at the same time as routine immunizations is safe. If multiple vaccines are due, giving more than one vaccine at the same visit is important because it increases the probability that an individual will be up to date with vaccines.

In addition, with both influenza and COVID-19 viruses circulating, getting both the Flu and COVID-19 vaccines is important for prevention of severe disease, hospitalization, and death. CDC recommends health care providers offer influenza and COVID-19 vaccines at the same visit, with each dose administered in separate limbs.

Omicron COVID-19 vaccine boosters now authorized for certain individuals

The Washington State Department of Health (DOH) and other healthcare providers will soon begin offering Omicron variant-targeted bivalent booster doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines following authorization by the U.S. Food and Drug Administration (FDA), and recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunizations Practices, and the Western States Scientific Safety Review Workgroup.  

The bivalent vaccines combine the companies’ original COVID-19 vaccine compositions with BA.4 and BA.5 spike protein components, providing additional protection by targeting variants that are more transmissible and immune-evading. The primary COVID-19 vaccine series will stay the same, given their proven efficacy in preventing serious illness, hospitalization, and death from COVID-19. DOH’s updated booster dose recommendations are as follows: 

  • People ages 12 – 17 who have completed a primary vaccine series can receive the Pfizer-BioNTech bivalent booster at least two months after their most recent dose. 
  • People 18 and older who have completed a primary vaccine series can receive either company’s bivalent booster at least two months after their most recent dose. 
  • Those ages 5 – 11 who have completed Pfizer-BioNTech’s primary vaccine series should continue to receive the company’s original monovalent booster at least 5 months after their most recent dose. 
  • Children ages 6 months – 4 years are currently not authorized for any COVID-19 booster doses. 
  • People ages 12 and over who currently have appointments to receive COVID-19 booster doses will need to contact their providers to ensure the bivalent booster is available; if not, those appointments will need to be rescheduled, as the former monovalent booster doses are no longer authorized for this age group. 

“We’re excited this updated bivalent booster will help increase protection against the Omicron variants as we head into the fall season,” said Tao Sheng Kwan-Gett, MD, MPH, Chief Science Officer. “As SARS-CoV-2 changes, so must the tools we use against it – this update helps ensure that vaccines and boosters will continue to be the most effective ways to reduce the risk of hospitalization and death, and keep those most at-risk healthy and safe.” 

An initial allocation of 191,100 bivalent booster doses is currently en route to providers throughout the state and will be available beginning the week of September 5 after the Labor Day holiday. Subsequent weekly allocations will follow, building the state’s inventory levels over time. DOH urges the public to remain patient, as we expect initial demand to exceed available inventory before resolving in the coming weeks, and to visit Vaccine Locator or call the COVID-19 Information Hotline at 1-800-525-0127 to find available resources near them. 

Department of Health releases updated COVID-19 guidance for K-12 schools & child care

The Washington State Department of Health (DOH) has released its updated COVID-19 guidance for K-12 schools and child care. The guidance takes lessons learned from the first two and a half years of the pandemic, and outlines both required and recommended measures for the 2022-23 school year to help reduce COVID-19 transmission in school and child care settings. Schools, child care providers, and families can expect limited changes focused on clarifying and simplifying the guidance.

“We are entering a new stage of coexisting with COVID-19 in our communities, knowing that COVID-19 is here to stay for the foreseeable future,” said Umair A. Shah, MD, MPH, Secretary of Health. “DOH also recognizes the importance of being able to maintain in-person learning for children, and the fundamental links between education and long-term health outcomes.”

Clarified requirements and recommendations in this school year’s guidance include:

  • Students, children, and staff who test positive for COVID-19 are required to stay at home and isolate for 5 days. Repeating initial COVID-19 testing will not affect this requirement.
  • Students, children, and staff returning from 5 days of isolation should wear a well-fitted mask from days 6 to 10. Those returning are encouraged to test before doing so.
  • Schools and child care providers are no longer required to directly notify high risk individuals of exposure but must continue to have a process in place to inform students, staff, and families of cases and outbreaks.
  • Schools and child care providers continue to be required to report outbreaks (3 or more cases within a specified core group) to local health jurisdictions (LHJ) and to have a system in place to respond.

DOH continues to encourage schools and child care providers to consider their local context when selecting any additional measures to help reduce COVID-19 transmission in schools and child care settings and to coordinate with their LHJ, particularly during times of outbreak. Schools, child care providers, and the LHJ may choose to continue to implement more protective measures, depending upon their context, to help ensure students, children, and staff can continue in-person activities safely.

While the guidance is specific to COVID-19 prevention, it can also help to reduce transmission of other common respiratory viruses such as influenza. DOH has also developed a brief for schools and a brief for child care providers to provide a high-level overview on changes to the guidance.

COVID-19 vaccinations remain the best protection for everyone against hospitalization and severe disease from COVID-19. The COVID-19 vaccine is now available for children 6 months and older. Booster doses are also available for children 5 years and older. DOH encourages all families to vaccinate their children if they are eligible, in consultation with health care providers.

CDC Recommends COVID-19 Vaccines for Young Children

Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all children 6 months through 5 years of age should receive a COVID-19 vaccine. This expands eligibility for vaccination to nearly 20 million additional children and means that all Americans ages 6 months and older are now eligible for vaccination. 

Parents and caregivers can now get their children 6 months through 5 years of age vaccinated with the Pfizer-BioNTech or Moderna vaccines to better protect them from COVID-19. All children, including children who have already had COVID-19, should get vaccinated.

COVID-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. history. Parents and caregivers can play an active role in monitoring the safety of these vaccines by signing their children up for v-safe – personalized and confidential health check-ins via text messages and web surveys where they can easily share with CDC how a child feels after getting a COVID-19 vaccine.

Distribution of pediatric vaccinations for these younger children has started across the country, and will be available at thousands of pediatric practices, pharmacies, Federally Qualified Health Centers, local health departments, clinics, and other locations this week. Children in this younger age group can be vaccinated with whichever vaccine is available (either Moderna or Pfizer-BioNTech). Parents can reach out to their doctor, nurse, local pharmacy, or health department, or visit vaccines.gov to see where vaccines for children are available.     

Read the full release from the CDC.