Moderna COVID-19 vaccine generates long-lasting immune memory

National Institutes of Health (NIH)

The Moderna and Pfizer mRNA vaccines against COVID-19 have shown greater than 90% effectiveness soon after the second dose. Studies suggest that protective immunity remains high, with only slight decreases, over six months. However, scientists are still working to understand how immunity against the virus develops after vaccination and changes over time.

Researchers believe that strong responses from both neutralizing antibodies and immune cells called T cells are necessary for immunity. Memory T cells linger in the body to recognize and protect against previously encountered pathogens. Recent studies indicate these may be crucial for lasting protection against COVID-19. 

A research team led by Drs. Daniela Weiskopf, Shane Crotty, and Alessandro Sette of the La Jolla Institute for Immunology looked at immune memory six months after vaccination. They were also interested in how immune memory from previous exposure to coronaviruses, which can cause common colds, might affect the vaccine-induced immune response.

The work was primarily funded by NIH’s National Institute of Allergy and Infectious Diseases (NIAID). Results appeared in Science on September 14, 2021.

The study examined 35 participants enrolled in a phase 1 clinical trial of the Moderna vaccine. They had received two 25-microgram injections—a quarter of the standard dose authorized for emergency use by the FDA.

The team assessed antibody and T cell levels after the first and second doses, and again six months later. They measured two subsets of T cells: CD8+ T cells, or “killer” T cells, which destroy virus-infected cells, and CD4+ T cells, “helper” T cells involved in antibody production.

Levels of antibodies, CD4+ T cells, and CD8+ T cells remained strong six months after receiving the vaccine. This was found even among participants over 70 years of age, who are particularly vulnerable to severe COVID-19. Memory CD4+ T cells were still present in nearly everyone six months after full vaccination. Memory CD8+ T cells were detected in 67% of participants six months after full vaccination. Until this study, it was uncertain whether the Moderna vaccine elicited these memory T cells. 

The team also found that the vaccine generated similar immune memory against the SARS-CoV-2 spike protein to that of natural infection. Levels of antibodies, CD4+ T cells, and CD8+ T cells six months after vaccination were comparable to those in recovered individuals.

In addition, the researchers found that “cross-reactive” T cells—those made during infection with other coronaviruses that can cause the common cold—enhanced the vaccine response. People with cross-reactive T cells before vaccination had significantly stronger CD4+ T cell and antibody responses.

Taken together, the study suggests that immune memory resulting from the Moderna vaccine, even at low doses, is long-lasting.

“The immune memory was stable, and that was impressive,” Crotty says. “That’s a good indicator of the durability of mRNA vaccines.”

—by Erin Bryant
 

Pfizer Booster for High-Risk Workers

In a statement released earlier this month, the CDC said that high risk of occupational exposure, such as healthcare workers, may receive the Pfizer booster shot at least 6 months after the two-dose primary series, based on their individual benefits and risks. The agency’s Advisory Committee on Immunization Practices (ACIP) had previously voted 6-9 against recommending a booster in this population.
 

Provider Relief Fund: Phase 4 Payments

Beginning September 29, 2021, providers can now apply for Phase 4 payments from the Provider Relief Fund, with application submission through the Provider Relief Application and Attestation Portal. Providers must submit their completed application by the final deadline of October 26 at 11:59 p.m.

The application will require the following documentation:

  • Applicant TIN and TINs for any subsidiaries included in the applicant TINs IRS tax filing.
  • Internally generated financial statements that substantiate operating revenues and expenses from patient care in 2019 Q1, Q3, and Q4; 2020 Q3 and Q4; and 2021 Q1.
  • Federal income tax return, audited financial statements, or internally generated financial statements submitted in their entirety.

Most providers who have completed their PRF reporting for initial funding, should have this information gathered already.

Following is an announcement from HRSA regarding the portal.  Please note that the announcement contains information regarding another webinar on the funding (Oct. 5).

Dear Partner –

The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), has announced a new application cycle for $25.5 billion in COVID-19 provider funding. Applicants will be able to apply for both Provider Relief Fund (PRF) Phase 4 and American Rescue Plan (ARP) Rural payments during the application process. PRF Phase 4 is open to a broad range of providers with changes in operating revenues and expenses. ARP Rural is open to providers who serve rural patients covered by Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP).

See a detailed list of eligible provider types here.

The application is open now and will close on October 26, 2021 at 11:59 p.m. ET. Providers who have previously created an account in the Provider Relief Fund Application and Attestation Portal and have not logged in for more than 90 days will need to first reset their password before starting a new application. In order to streamline the application process and minimize administrative burdens, providers will apply for both programs in a single application.

HHS recently hosted a briefing session to provide information about these upcoming funding opportunities – view the video here. HRSA will also host webinar sessions featuring guidance on how to navigate the application portal. Register now using the links below.

Real time technical assistance is available by calling the Provider Support Line at (866) 569-3522, for TTY dial 711. Hours of operation are 8 a.m. to 10 p.m. CT, Monday through Friday.

Marvin Figueroa, Director 

Office of Intergovernmental and External Affairs

U.S. Department of Health and Human Services

Washington, D.C.
 

USING YOUR BUDGET FOR CALCULATING LOST REVENUES FOR PRF REPORTING (From The Health Group) 

Three methods are available to healthcare providers for determining lost revenues eligible to be applied as a qualified use of Provider Relief Funds.  These are:

  • Option 1: Actual 2020 and 2021 revenues compared against 2019 revenues,
  • Option 2: Actual 2020 and 2021 revenues compared against 2020 budgeted revenues, or
  • Option 3: Alternate lost revenue computation.

We have received numerous inquiries regarding the use of budgeted revenues in the determination of lost revenues.  The following is provided by HRSA relating to the use of budgeted information:

“Lost revenues are calculated for each quarter during the period of availability, as a standalone calculation, with budgeted quarters serving as a baseline. For each calendar year of reporting, the applicable quarters where lost revenues are demonstrated are totaled to determine an annual lost revenues amount. The annual lost revenues for the years included in the period of availability are then added together. There is no offset.

Reporting Entities may use budgeted revenues if the budget(s) and associated documents covering the Period of Availability were established and approved prior to March 27, 2020.”

“When reporting use of Provider Relief Fund payments toward lost revenues attributable to coronavirus, Reporting Entities may use budgeted revenues if the budget(s) and associated documents covering calendar year 2020 were established and approved prior to March 27, 2020. To be considered an approved budget, the budget must have been ratified, certified, or adopted by the Reporting Entity’s financial executive, executive officer, or other responsible representative as of that date, and the Reporting Entity will be required to attest that the budget was established and approved prior to March 27, 2020. Documents related to the budget, including the approval, must be maintained in accordance with the Terms and Conditions.

https://www.hrsa.gov/sites/default/files/hrsa/provider-relief/prf-lost-revenues-guide.pdf specifically identifies the 2020 Budgeted Revenue as the basis for calculating budgeted revenues versus actual revenues for 2020 or 2021.

Many consultants are informing providers that they need a budget for 2021 for comparison to the actual revenues for the first two (2) quarters of 2021.  Other consultants are recommending the use of budgeted revenues for 2020 to actual revenues for 2020; however, they recommend using actual revenues for the first two (2) quarters of 2020 to be compared against actual revenues for the first two (2) quarters of 2021.

It is no wonder why many providers are confused.  HRSA has presented the following information which clearly indicates that a qualifying 2020 budget is not only used for comparison to actual 2020 revenues, but also that the first two (2) quarters of the 2020 budget are used for comparison against actual revenues for the first two (2) quarters of 2021.  As evidenced by the HRSA presentation, the first two (2) quarters of the 2020 budget are repeated for comparison against the 2021 actual revenues to determine lost revenues.

All providers are responsible for their submission and, accordingly, must select the process for identifying lost revenues; however, we believe the following as presented by HRSA is clear regarding the use of a qualifying 2020 budget (approved before March 27, 2020) solely as the basis against which actual revenues will be compared for both 2020 and the first two (2) quarters of 2021.  This approach makes sense as the 2020 budget would have been developed and accepted (before March 27, 2020) without considering any COVID-19 PHE impact, thus providing an appropriate comparison to actual revenues generated.

The entire HRSA presentation regarding “Period of Availability and Lost Revenues" is available here.  The information presented in the above slide has not been altered by any of the subsequent information released by HRSA.
 

COVID Vaccine For Kids Ages 5 To 11 Is Safe And Effective, Pfizer Says

Matt Rourke/AP

The first results from the highly anticipated trial studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children ages 5 to 11 showed promising results.

The pharmaceutical companies said early results of their trial indicate the vaccine is safe for children and establishes a strong antibody response against the virus.

Giving a two-dose regimen of 10 μg (micrograms) administered 21 days apart for children between 5 and 11 years old was well tolerated, according to Pfizer and BioNTech. Side effects were also generally comparable to those of people between the ages of 16 and 25 years old who received the vaccine.

This trial used a smaller vaccine dosage, 10 micrograms, rather than the 30 microgram dose used for people 12 and older. The dosage was selected as the preferred dose for safety and effectiveness in young children.

News of the results come as pediatric cases of COVID-19 are increasing amid a nationwide surge of infections.

"Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency," said Albert Bourla, the chairman and CEO for Pfizer.

"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children," Bourla said in a statement.

Despite the strong results, it will be some time before the general public can see an official rollout of vaccines for children ages 5 to 11. Once analysis of the trial is completed, Pfizer and BioNTech will submit the results "in the near term" to the Food and Drug Administration for review and possible emergency use authorization.

A Vaccine For Children Is Not Likely To Be Approved Until The End Of Year

And even if the FDA grants that authorization, Dr. Francis Collins, director of the National Institutes of Health, recently told NPR that parents and caregivers will likely have to wait until the end of 2021 before a COVID-19 vaccine is fully approved for young children ages 5 to 11.

Trial results for children under 5 years of age could come later this year, the pharmaceutical companies said.

"Already in March 2021, we have started the study to evaluate the immunization of younger children. Our objective was to generate and submit the data for schoolkids to regulatory authorities around the world before the winter season begins," BioNTech CEO and co-founder Ugur Sahin said.

 
 
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