COVID-19 Updates: Pfizer Starts Trial of COVID and Pneumococcal Vaccines, CDC Reviews Vaccine-Related Myocarditis in Youths, Vaccine Trials for Young Children

Doctor injecting COVID-19 vaccine into young boy's arm

At least 167 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, May 24, 2021, including at least 3.47 million deaths. Healthcare officials in the United States have reported at least 33.1 million positive COVID-19 cases and at least 590,000 deaths. Source: Johns Hopkins University & Medicine

At least 1.67 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 286 million in the United States. Source: GitHub

Pfizer starts trial of COVID and pneumococcal vaccines

A trial to assess the safety of administering a valent pneumococcal conjugate vaccine candidate after a booster dose of the COVID-19 vaccine will soon be underway, according to officials with Pfizer.

The first enrolled subjects of what is expected to be a trial including 600 adults ages 65 and older have received their immunizations. Follow up will reportedly occur six months after vaccination. Secondary objectives of the trial are to describe immune responses produced by each of the vaccines. Participants are being recruited from the Phase 3 Pfizer-BioNTech COVID-19 vaccine trial. The participants are being randomized to one of three groups:

  • Valent pneumococcal conjugate vaccine plus Pfizer-BioNTech COVID-19 vaccine booster, which is a third dose of the Pfizer-BioNTech COVID-19 vaccine
  • Valent pneumococcal conjugate vaccine plus placebo
  • Pfizer-BioNTech COVID-19 vaccine booster plus placebo

More information on the trial can be found here.

CDC committee reviews vaccine-related myocarditis in youths

Reports of heart problems occurring in young adults and teenagers who have received the mRNA two-dose COVID-19 vaccines have led health officials with the Centers for Disease Control and Prevention (CDC) to investigate.

According to the CDC’s Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccine Safety Technical (VaST) Work Group, “relatively few” incidents of myocarditis have been seen among these patients.

VaST has also concluded that these cases seem to occur predominantly in adolescents and young adults, males, following the second dose, and typically within four days of vaccination.

Most cases appear to be mild, and follow-up of cases is ongoing, according to the CDC.

Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates. However, VaST members felt that information about reports of myocarditis should be communicated to providers.

VaST also shared the following guidelines:

  • Further information should be collected through medical record review about potential myocarditis cases that were reported into the Vaccine Adverse Event Reporting System (VAERS).
  • Information about this potential adverse event should be provided to clinicians to enhance early recognition and appropriate management of persons who develop myocarditis symptoms following vaccination.
  • Collaboration between infectious diseases, cardiology, and rheumatology specialists is needed to provide guidance on diagnosis, treatment, and management of myocarditis.

The Food and Drug Administration (FDA) has authorized the Pfizer COVID-19 vaccine for minors 12 and older while the Moderna vaccine is currently authorized for people 18 and older. The safety group did not specify which vaccine was given in these cases, according to a report by USA Today.

Vaccine trials begin for toddlers and infants

Children ages 5 years old and younger in the United States have been enrolled to take part in a Phase 1 clinical trial to test the Pfizer-BioNTech COVID-19 vaccine. A separate Phase 2-3 trial to determine whether the vaccine produces an immune response and prevents COVID-19 in children ages 5-11 years old is also underway.

Stanford Medicine is a test site for both trials, according to a recent news release from the university.

“Children under 18 make up about a quarter of the U.S. population, so if we want to get the virus under control and make sure we have as many people protected by vaccines as possible, we really need to include them,” said Yvonne Maldonado, MD, professor of pediatrics and of epidemiology and population health at the Stanford University School of Medicine, in a prepared statement. “Even though the risk in children appears to be lower than in adults, this is still an important, potentially vaccine-preventable illness in kids.”

Children enrolled in the Phase 1 trial will receive two injections of the vaccine and undergo blood draws to check for antibodies to the virus. Once a safe dose of the vaccine has been determined, further trials will be conducted to determine its effectiveness.

The Phase 2-3 study is placebo-controlled, according to Stanford officials. Six months after the shots, participants who received the placebo will have the opportunity to be inoculated with the actual vaccine. The trial will continue for 18 more months, during which both groups will undergo blood draws to track the strength and duration of their immune response and to see if they are infected with COVID-19.

Booster vaccine doses to be expected?

An additional administration of a COVID-19 vaccine could be needed among fully vaccinated individuals within 8-12 months, according to a recent report by CNN citing Albert Bourla, chief executive officer at Pfizer, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

According to the report, circulating strains that could continue to mutate quickly could cause immunity from the vaccine to be diminished over time.

A trial led by the University Hospital Southampton NHS Foundation Trust in the United Kingdom is reportedly studying the impact of seven different Covid-19 vaccines when given as a third dose while the Centers for Disease Control and Prevention is assessing whether a booster specific to variants will be needed.

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