The United States (US) Food and Drug Administration (FDA) recently authorized the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11 years old. The Centers for Disease Control and Prevention (CDC) also recommended the vaccine in this age group. There are 28 million children in the US ages 5 to 11 years old. This age group makes up 39% of COVID-19 cases in those under the age of 18 years. While children are less likely to develop severe COVID-19 than adults, severe illness, hospitalization, and death have occurred in younger ages. Now that there is a COVID-19 vaccine option for ages 5 to 11 years, here are answers to vaccine questions that are top of mind for many parents.

1. How effective is Pfizer’s vaccine in children ages 5 to 11 years?

• According to results from the ongoing study in ages 5 to 11 years, the vaccine has been 90.7% effective in preventing COVID-19 measured 7 days after the second dose. The study has been going on with delta as the prevalent strain.
• Immune responses in this age group were comparable to 16 to 25-year-olds.

2. What are the common side effects?

• The most common side effect was injection site pain (sore arm). Some of the other common side effects include fatigue, headache, redness and swelling, fever, chills, and muscle pain.
• Side effects were generally more common after the second dose. Side effects were mostly mild to moderate, started within 2 days of the second dose, and resolved within 1 or 2 days.
• There have been no cases of myocarditis (heart inflammation) reported in this age group.
• The study is ongoing, and the FDA and CDC will continue to monitor for vaccine safety and look for rare or serious side effects.
• The vaccine should not be given to anyone who has a history of anaphylaxis (severe allergic reaction) to any part of Pfizer’s vaccine.

3. How is Pfizer’s vaccine dosed in ages 5 to 11 years? What type of vaccine is it?

• The dose for 5 to 11-year-olds is a two-dose regimen of 10 mcg given 21 days apart.
• It is a messenger RNA (mRNA) vaccine, but the dose is one-third of the adolescent and adult doses (30 mcg).

4. Can the flu and COVID-19 shots be given at the same visit?

• COVID-19 vaccine can be given at the same visit as routine childhood immunizations, including flu.

5. Where is Pfizer’s vaccine available?

• Pfizer’s vaccine for ages 5 to 11 years is available in pediatrician offices, pharmacies, health departments, hospitals, and other sites.  Vaccines.gov lists vaccine availability at different locations.

Disclaimer: The content in this blog article is NOT a substitute for professional medical advice. For questions regarding COVID-19 vaccines, any medical condition, or if you are in need of medical advice, please contact your healthcare provider. Given the fluid nature of the pandemic, information in this article is subject to change and may not be current.

Sources

• VRBPAC FDA Briefing Document. October 26, 2021. https://www.fda.gov/media/153447/download
• Pfizer EUA Press Release. October 29, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-fda-emergency-use-0.
• FDA Press Release. October 29, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age
• CDC Interim Clinical Considerations. November 3, 2021. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#children
• Pfizer EUA Fact Sheet. Revised October 29, 2021. https://www.fda.gov/media/153714/download
• AAP Policy Statement. November 2, 2021. https://www.aap.org/en/pages/covid-19-vaccines-in-children-and-adolescents-policy/
• Vaccines.gov.

As the new COVID-19 vaccine is being administered across the country, many people are feeling a mix of emotions. There is hope that the vaccine will normalize life and relief that the vaccine will save lives.  There is also anxiety about its potential side effects, long-term effectiveness and availability. For some, the stress and uncertainty caused by the pandemic are being exacerbated by vaccine concerns.

Vaccine safety

Although the two vaccines currently available were rapidly developed, they meet the safety and efficacy standards of the U.S. Food and Drug Administration (FDA). The data from the manufacturers and research from large clinical trials show that the benefits of the COVID-19 vaccines outweigh the risks of side effects and coronavirus infection. There are also other COVID-19 vaccines in development that must meet stringent safety standards before they can be released.

In addition, the Centers for Disease Control (CDC) and FDA have expanded safety monitoring systems to continue to track possible side effects of vaccines. A new easy-to-use, smartphone-based tool called V-safe enables vaccinated individuals to notify the CDC about any side effects. V-safe also texts reminders to get the second vaccine dose.

Anxiety about the COVID-19 vaccine

Anxiety can stem from fears about the vaccine’s safety, getting a shot or not having control over when it will be available.

Here are tips to help manage it:

• Stay informed and research credible sources. There is a lot of misinformation online about vaccinations in general. Follow credible news and information sources. Up-to-date information about the COVID-19 vaccines, side effects and benefits, and answers to frequently asked questions, are available on the CDC website.
• Follow recommended guidelines to keep yourself safe. It will likely take months for the COVID-19 vaccine to be available to anyone who wants it. In the meantime, take precautions to protect yourself and your family by wearing masks, maintaining social distance and washing your hands frequently. Minimize your risk of contracting the virus by following CDC guidelines on travel, gatherings and other activities that can spread the virus.
• Make self-care a priority and consistently practice ways to cope with stress. Anxiety can result from a feeling of lack of control and uncertainty, and the pandemic was the perfect storm of both. Get enough sleep, eat nutritious foods, exercise and take time every day for an activity you enjoy.

Finally, remember that feelings of stress and anxiety during difficult times are normal and will pass. If you find that anxiety continually affects your quality of life and you feel overwhelmed, consider talking to a mental health professional.

To learn more about Magellan Healthcare’s mental and behavioral health resources, click here. 

Source: Centers for Disease Control and Prevention

The coronavirus disease 2019 (COVID-19) pandemic has taken a substantial toll on human life, not to mention our way of life. With over 14 million confirmed global cases and the death toll approaching 612,000, it is one of the most significant crises in recent history. In the United States (US), the country with the most cases and deaths, confirmed cases exceed 3.8 million and over 141,000 deaths have been reported as a result of this outbreak. As cases surge in certain parts of the country and the world, safe and effective vaccines and therapies are crucial to combatting this virus.  

Currently, there are no US Food and Drug Administration (FDA)-approved treatments or vaccines for SARS-CoV-2, the virus that causes COVID-19. Over 200 agents are being evaluated to treat the virus. These include new emerging molecular entities as well as approved drugs that are already available to treat other conditions and now being repurposed for COVID-19. According to the World Health Organization (WHO), 24 vaccine candidates have entered human trials and over 140 vaccine hopefuls are in preclinical evaluation.

Scientists around the world are working tirelessly to discover a vaccine for COVID-19. Vaccines candidates go through many stages of study. The average time to develop a vaccine ranges from 10 to 15 years. The Ebola vaccine, newly-minted in December 2019, only took about 6 years to be approved, whereas an HIV/AIDS vaccine has still not come to market after about 40 years. Given this pandemic’s magnitude, extraordinary measures from public and private stakeholders have been introduced to accelerate vaccine development.

COVID-19 has presented us with many challenges. Mitigation measures and safe and effective vaccines and treatments are key to restoring a new normalcy.