Q: What is the current status of COVID-19 vaccine research in children and adolescents?
A: As of March 30, 2020Pfizer, BioNTech reported that their COVID-19 vaccine is safe and highly effective in adolescents 12-15 years old. The company is planning to submit their data for FDA approval in the coming weeks.
Currently the Pfizer COVID-19 is not yet approved for individuals under the age of 16. There is also no update as to when it will be commercially available. Please be assured Northern Virginia Pediatric Associates is closely monitoring the progress of this vaccine and plans on accommodating our patients if and when the vaccine is made available to private practices.
The hope is that the FDA will approve the vaccine quickly and, we will be able to begin vaccinating younger children in time to return to school in the fall.
Virginia Governor Ralph Northam has announced that ALL individuals 16 years and older will be able to register for the COVID-19 vaccine beginning April 18th. Click here for more information and how to register.
The AAP has advocated for the inclusion of children and pregnant women in COVID-19 vaccine trials, including letters to the FDA
Q: Are there any data from volunteers who happened to get pregnant or who were breastfeeding during vaccine trials? Any effects of COVID vaccine on pregnancy, the developing fetus, or infants?
A: No pregnancy related data have yet been released. Typically, in large trials, there are some inadvertent pregnancies. They will be followed for birth outcomes. Pregnancy and breastfeeding will probably not be contraindications to receiving COVID-19 vaccine; however, there is no safety data in the pregnant woman, her fetus or infants at this time. While these vaccines were not specifically tested in breastfeeding women, it is not likely (based on the mechanisms of action of the vaccines in US trials) that there would be any risk to the child.
Q: Are there any safety concerns with the new technologies (mRNA and nanotechnology) being used in the development of COVID-19 vaccines?
A: There are no known additional risks of mRNA vaccines or lipid nanoparticles. Live attenuated viral vaccines, such as measles vaccine, induce an immune response that is similar to natural infection. mRNA vaccines, on the other hand, simply give the body instructions to produce one very specific part of a virus – in this case the so-called spike protein – to then induce an immune response. Because mRNA is broken down very quickly in the human body, to do its work it needs to be able to get into our cells, and so it is wrapped in a lipid nanoparticle. Once it gets into the cells to deliver the instructions, the mRNA breaks down very quickly. It does not get into the nucleus of the cell, or into our genes.
Q: How quickly after immunization does the vaccine protect the recipient, and how long does immunity last?
A: The current studies start counting cases for efficacy at 7 to 14 days after the second dose, which is likely how long it takes to get very high levels of neutralizing antibody. Only one manufacturer among those furthest along could potentially have a one-dose vaccine (Janssen).
It is yet unknown how long immunity will last; however, these data will be continuously updated.
The first Pfizer vaccine recipients (a relatively small number) received vaccine in May 2020. Individuals in Phase 3 trials received vaccine 2-3 months ago, so additional information about durability will be forthcoming.
Side Effects and Safety Monitoring
Q: What adverse outcomes/side effects are noted to date with COVID-19 vaccine?
A: The side effects have been similar to other routine vaccines- sore arm, redness, fatigue, fever, chills, headache, myalgia, arthralgia. The side effects are temporary and mostly mild or moderate. Side effects may be worse after the second dose in some. A full listing will be provided once the vaccines are available. As health care personnel will be vaccinated first, the potential for side effects that cause individuals to miss work should also be considered in planning.
Q: What is the safety testing that has been done on COVID-19 vaccines? How do we know it is safe long-term?
A: The safety follow-up for COVID-19 vaccines is essentially the same that it is for all vaccine trials. The expectation for the adult phase 3 trials is 2 years of safety follow-up – longer than for most vaccines during development. It is impossible to know the very long-term safety profile of vaccines that have only been in humans for about 6 months. That said, no vaccines yet licensed have been found to have an unexpected long-term safety problem, that was found only years or decades after introduction.
Additionally, the US has a robust vaccine safety monitoring system that has been in place and operating behind the scenes for decades. There will be expanded monitoring for COVID-19 vaccine, including a new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines called V-SAFE.
Vaccine Distribution and Prioritized Populations
Q: Can/Should those who have had a previous SARS-CoV-2 infection wait to get vaccinated?
A: It is expected that all persons in the phased risk categories, regardless of prior infection, will be eligible for vaccine. It is also anticipated that vaccination will be recommended regardless of prior infection. While vaccine supplies are constrained, vaccination of persons with recent prior infection may be delayed; however, the duration of protection after infection is unknown.
Q: Will there be a vaccine available for children before the 2021-22 school year?
A: This will depend on the results of the trials of the vaccine in adolescents and children that are planned or underway now. But based on the current pace of research, it is potentially achievable that we will have a vaccine for at least some age groups of children and adolescents before the 2021-22 school year begins.
Q: Will the vaccine be required for school entry?
A: When a vaccine is shown to be safe and effective in children, health authorities, including the CDC and the AAP, will make recommendations on when and how children should receive the vaccine. However, it is a state government decision which vaccines are required for school entry. Those decisions could vary by state.
Q: Can COVID-19 vaccine be co-administered with other childhood or adolescent immunizations?
A: Until we have a COVID-19 vaccine for children, we need to focus on getting children caught up and keeping them up-to-date on routinely recommended vaccines. Under-vaccinated children will be at greater risk of other vaccine preventable illnesses such as measles, pertussis, and influenza unless they are fully vaccinated.
Administration of the COVID-19 vaccine with other childhood or adolescent immunizations has not yet been tested. There are very few vaccines in which co-administration with other vaccines is problematic. This topic needs to be studied, especially in the youngest children who receive vaccines at so many of their visits.
Q: Children are much less likely than adults to have severe disease from COVID-19, so why do they need to be vaccinated?
A: COVID-19 can cause significant illness in children. In children for whom COVID-19 caused serious illness, half had an underlying condition, and half did not. This is similar to influenza. We need to vaccinate children because we do not know which children may be at higher risk of serious, possibly life-threatening illness. Children can also transmit the virus, including to more vulnerable adults who are in their family or in their school, so it is important that children be included in the vaccine distribution in order to reduce community spread.
Q: Would you still recommend continuing full precautions after vaccination until community immunity is reached?
A: Yes! We will need to continue to practice physical distancing, wearing cloth face coverings and masks, and using PPE during medical encounters for some time after the vaccine is introduced. It will be some time before there is evidence that the vaccines not only prevent illness in the person who is vaccinated, but also prevent them from transmitting the virus. Until then we will need to practice these public health measures. Pediatricians can help by explaining this to families in their practice. Life will not return to “normal” immediately after a vaccine is introduced.