Opinion | I monitor meetings of the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) for the National Vaccine Information Center (NVIC). On May 10, 2021, the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) granted Pfizer/BioNTech to distribute its experimental mRNA vaccine in the U.S. to include administration to children as young as 12 years old.1 On May 12, 2021, I listened to the emergency meeting at which the ACIP voted 14-0 with one abstention (due to conflicts of interest) to recommend the Pfizer vaccine for adolescent children.2
The evidence that ACIP used to make their recommendation was based on results of a very small Pfizer clinical trial that the FDA has stated included:
2,260 participants ages 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose.3
Based on less than 1200 adolescents who were administered the Pfizer COVID-19 vaccine, the ACIP voted to recommend that the experimental vaccine can be given to every adolescent in the U.S. and said it can be given simultaneously with every other vaccine recommended by the CDC for adolescent children. So the CDC says it is okay for a 12-year-old to get the experimental Pfizer COVID-19 vaccine along with vaccines for influenza, HPV, Tdap and meningococcal on the same day.4
No Information on Co-administration of Pfizer COVID-19 Vaccine with Other Vaccines
The FDA’s May 10 Fact Sheet for Health Care Providers states that, “There is no information on the co-administration of the Pfizer/BioNTech COVID-19 vaccine with other vaccines.”5
Where is the scientific data to support safety of the ACIP recommendation that adolescents can get the Pfizer COVID-19 vaccine simultaneously with other vaccines? Or that adults, including pregnant women, can receive a COVID-19 vaccine at the same time as any other recommended vaccine?
There is none.
The CDC reported that the recommendation to administer COVID-19 vaccines independently of any other vaccine product, with a minimum interval of 14 days before or after administration of any additional vaccine, was done to gain a better understanding of potential reactions associated with these novel vaccines. They are now reporting that “substantial” safety data has been collected on COVID-19 vaccines and went on to justify the change in their recommendation by stating:
Extensive experience with non-COVID-19 vaccines has demonstrated that immunogenicity and adverse event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone.6
In other words, we give multiple vaccines all the time, so why should administering the COVID-19 vaccine with any other vaccine be problematic?
How Can People Exercise Informed Consent with No Scientific Data?
What’s especially concerning about this new guidance is the fact that millions of unsuspecting teens, adults including pregnant women and those with underlying health conditions, and elderly, will now be at an increased risk of potential harm from simultaneous vaccination. COVID-19 vaccine will now be given with vaccines that contain adjuvants such as aluminum, squalene, synthetic DNA, and more. Adjuvants that are designed to stimulated the immune response and are known to cause both local and systemic reactions.7
Because, in all honesty, does anyone actually believe that most doctors and vaccine providers will give individuals and parents true, informed consent, by advising them of the lack of safety data on simultaneous vaccination prior to administering the experimental COVID-19 vaccine with another vaccine?8 9 10
Committee members commented that the agency will be able to track any potential problems that occur after persons, including children between 12 and 15 years old, get the vaccine through the Vaccine Adverse Event Reporting System (VAERS). However, they said that V-Safe,11 which is a separate CDC operated internal vaccine adverse event reporting system that only monitors COVID-19 vaccines and is not open to public viewing like VAERS, also will be used. If this is the case, will reports on co-administration of COVID-19 vaccines with other vaccines be captured in the V-Safe program?
The ACIP and liaison members were more concerned about Americans being behind on getting any vaccine, including the COVID-19 shot than they were about any potential safety issues. While some ACIP members expressed concern that certain licensed vaccines were known to be reactogenetic and giving them in conjunction with the COVID-19 vaccine might be problematic, most members felt that giving additional vaccines with the COVID-19 vaccine was a great idea.12 13
Pfizer COVID-19 Vaccine Reactions Common in Adolescents
It was disturbing to listen to the discussions. The presentations strongly promoting giving the Pfizer experimental COVID-19 vaccine to 12- to 15-year-olds were especially difficult to listen to because the scientific evidence to support the recommendation is just not there.
Pfizer’s clinical trial data revealed there were more detected COVID cases in the placebo group (18) than in the vaccinated group (0) of 12- to 15-year-old participants. However, none of the participants in either the vaccinated or unvaccinated arms of the trial experienced COVID illness that required hospitalization.
In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).
ACIP also reported that during the clinical trial, nearly 11 percent of 12- to 15-year-olds experienced a severe or Grade 3 vaccine reaction, with one study participant experiencing a Grade 4 reaction of a fever of 40.4°C. Five adolescents who received the Pfizer vaccine experienced a serious adverse event (SAE) during the trial, however, none of these events were considered by clinical trial investigators to be related to vaccination.16
Pfizer COVID-19 Vaccine Clinical Trial in Adolescents Lacked Ethnic Diversity
If the very small number of teens enrolled in the clinical trial were not disturbing enough, the number of minorities represented in clinical data should have been enough to question whether the vaccine would be safe to give to a diverse population. According to Pfizer, out of 1,131 adolescents who received the vaccine, only 152 teens from differing ethical and racial backgrounds other than white received the experimental vaccine. This included 52 black or African Americans, 4 Alaska Native or American Indians, 72 Asians, 3 Pacific Islanders or Native Hawaiians, and 23 teens who identified as being multiracial. While 971 teens were identified as being Caucasian, only 132 were of Hispanic/Latino descent.17
Given that the FDA acknowledges that persons of different races and ethnic backgrounds “may react differently to certain medical products,”18 it is disheartening that federal public health regulatory and policymaking agencies considered this small sample size to be adequate to make a broad based universal use recommendation, especially for an unapproved product that will now be administered to millions of adolescents.19
No Delay of COVID-19 Vaccinations, Even for Those With Active SARS-CoV-2 Infections
Prior to the vote, ACIP voting member Henry Bernstein, MD questioned the timing of COVID-19 vaccination in teens with an active SARS-CoV-2 infection and was informed that there were no recommendations to delay vaccination in persons with an acute COVID-19 infection, including adolescents, as it could result in a “missed opportunity for vaccination in this population.”20 This recommendation could have significant consequences given that persons with pre-existing immunity to SARS-CoV-2 who received mRNA COVID-19 vaccines have been noted to have significantly higher rates of systemic reactions (fatigue, headache, chills, fever, joint or muscle pains) when compared to those who were not immune at the time of vaccination.21 22
In their statements after the vote, the ACIP members kept stating that it was wonderful that the adolescent and teenage child population can now contribute to herd immunity. Nobody discussed the fact that the EUA was originally granted to Pfizer based on evidence that experimental mRNA COVID-19 vaccine prevents severe COVID symptoms, hospitalizations and death—not that the vaccine prevents infection and transmission of SARS-CoV-2.23 24
We did learn that 25 percent of those involved in the trial among 12 to 15 year olds—all 2260 of them (1131 in the vax, 1,129 in the control)—had a pre-existing psychiatric disorder. And in the course of discussions, it was stated that this is the baseline for the U.S. population.25 26
No Cost Effectiveness Studies for Universal Use of Pfizer COVID-19 Vaccine by Adolescents
When ACIP reviewed the evidence for why the vaccine should be recommended for 12 to 15-year olds, the first point discussed on whether this was a reasonable use of resources was that the U.S. government had purchased a total of 600 million doses of experimental COVID-19 vaccines (300 million doses from Pfizer) to be delivered to the U.S. population in increments by the end of July. The second point was that the vaccine was administered to Americans for free.29
There are no cost effectiveness or other benefit/risk studies on the routine use of Pfizer’s experimental mRNA COVID-19 vaccine in the 12- to 15-year-old population, a population that has not been hard hit by COVID-19. Most infants and children have mild or no symptoms and very few experience COVID-19 complications,30 but CDC is making the argument that getting adolescents vaccinated will ensure that schools can reopen in the fall of 2021. They also reported that school closing and associated costs due absenteeism from work/school due to contact tracing and quarantine could be as high as $15 trillion and that getting all children vaccinated should help reduce these costs.31
COVID-19 Vaccines Must Be Administered According to Applicable State Laws
CDC officials described their implementation strategy for vaccinating 12- to 15-year-olds, which included promoting the vaccine “as quickly and equitably as possible through a multi-pronged approach.” This included increasing the number of vaccine providers that can target teens, utilizing pharmacies, and promoting school-based vaccination programs. While noting that no federal or legal requirement existed regarding parental consent for COVID-19 or any other vaccination, the CDC acknowledged that “COVID-19 vaccine must be administered according to applicable state and territorial vaccination laws, including those related to consent.” 32
Most states require parental or caregiver consent for children and teens under the age of 18,33 however, the District of Columbia permits vaccination of minors 11 years of age and older without parental knowledge or consent. This law, which went into effect on Mar. 16, 2021, does not differentiate between FDA approved vaccines or those authorized by EUA.34
More Reports of Blood Clots After Johnson & Johnson Covid-19 Vaccinations
In April, FDA and CDC officials temporarily suspended recommendations for use of the Johnson & Johnson/Janssen human adenovirus vectored COVID-19 vaccine due to reports of blood clots in younger women. On Apr. 23, they lifted the “pause” after they said they had conducting a “thorough safety review.”35
During the ACIP meeting, the CDC gave an update on thrombosis with thrombocytopenia syndrome (TTS) following Johnson & Johnson/Jannsen COVID-19 vaccinations and acknowledged that additional cases have been reported.36 As of May 7, 2021, 28 cases and 3 deaths had been confirmed by the CDC to be related to the vaccine. TTS has also been reported in men and in women between 50 and 60, in addition to women between 18 and 49 years. 37
The COVID-19 Vaccine Safety Technical (VaST) Work Group, however, concluded that “the benefits still outweighed the risks at this time, and no updates to vaccine policy are needed at this time.”38
According to the data presented, among women between 40 and 49 years of age, TTS occurred at a rate of 1 in 81,000 doses administered. Some ACIP members expressed significant concern that the J&J vaccine was still being used in individuals, especially women, under the age of 60, and requested that the committee consider revising the recommendation guidelines. In particular, it was noted that the warning of TTS was specific to women between 18 and 49 years of age even though cases have occurred in persons 50 and older, and in men.39
In the discussions following the safety presentations, ACIP voting member commented that she was personally aware of three young women who were given the J&J COVID-19 vaccine and not provided with information on the risk of TTS. Long expressed significant concern that women in the high-risk populations were not being provided with informed consent and information on alternative vaccines, and she questioned the work group on how much data would need to be collected before a revision in the recommendation would be made.40
The VaST working group reported that safety data monitoring was ongoing and when/if changes to the recommendation was needed, they would present this information at a future ACIP meeting, with any recommended policy change.41
All in all, it was a bad day for our kids and for our population as a whole.
If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.
Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers. The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.
Click here to view References:
1 U.S. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic. May 10, 2021.
2 Advisory Committee on Immunization Practices. Emergency Meeting on COVID-19 Vaccine Recommendations. May 12, 2021. Final Meeting Agenda.
3 FDA. Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic. May 10, 2021.
4 Woodworth K. Clinical Considerations for Pfizer-BioNTech COVID-19 Vaccination in Adolescents. U.S. Centers for Disease Control and Prevention May 12, 2021.
5 FDA. Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). May 10, 2021.
6 Woodworth K. Clinical Considerations forPfizer-BioNTech COVID-19Vaccination in Adolescents. CDC May 12, 2021.
7 U.S. Centers for Disease Control and Prevention. Adjuvants and Vaccines. Aug. 14, 2020.
8 FDA. Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). May 10, 2021.
9 FDA. Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). Mar. 31, 2021.
10 FDA. Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Janssen COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). Apr. 23, 2021.
11 CDC. V-Safe After Vaccination Health Checker. Apr. 21, 2021.
12 YouTube. COVID-19 Pfizer Vote on vaccine in 12-15-year-olds. May 12, 2021.
13 Serebrov M. ACIP says yes to EUA expansion, caught off-guard by change in CDC guidance. BioWorld May 12, 2021.
14 CDC. COVID-19 in Children and Teens. Mar. 17, 2021.
15 FDA. Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). May 10, 2021.
16 Wallace M. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): Pfizer-BioNTech COVID-19 Vaccine. CDC May 12, 2021.
17 Perez JL. COVID-19 VaccineBNT162b2 Safety, Immunogenicity, and Efficacy in Subjects 12–15-years-old. CDC May 12, 2021.
18 FDA. Clinical Trial Diversity. May 13, 2021.
19 Goodman B. FDA Set to OK Pfizer Vaccine in Younger Teens. WebMD May 4, 2021.
20 YouTube. COVID-19 Pfizer Vote on vaccine in 12-15-year-olds. May 12, 2021.
21 Krammer F, Srivastava K, The PARIS team, et al. Robust spike antibody responses and increased reactogenicity in seropositive individuals after a single dose of SARS-CoV-2 mRNA vaccine. medRxiv Feb. 1, 2021.
22 Lee M. People Who Recovered From COVID-19 Should Receive Only 1 Dose of Vaccine: Study. The Epoch Times Feb. 5, 2021.
23 FDA. Pfizer-BioNTech COVID-19 Vaccine. Dec. 11, 2020.
24 YouTube. COVID-19 Pfizer Vote on vaccine in 12-15-year-olds. May 12, 2021.
25 National Alliance on Mental Illness. Mental Health by the Numbers. May 2021.
26 NAMI. Any Anxiety Disorder. November 2017.
27 Oliver S. EtR Framework: Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years. CDC May 12, 2021.
28 CDC. Childhood Obesity Facts: Prevalence of Childhood Obesity in the United States. Apr 5, 2021.
29 Oliver S. EtR Framework: Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years. CDC May 12, 2021.
30 Mayo Clinic. COVID-19 (Coronavirus) in babies and children. May 6, 2021.
31 Oliver S. EtR Framework: Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years. CDC May 12, 2021.
33 National Vaccine Information Center. State Laws & Vaccine Requirements.
34 Council on the District of Columbia. B23-0171 – Minor Consent for Vaccinations Amendment Act of 2019.
35 CDC. FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Through Safety Review. Apr. 23, 2021.
36 Erman M, Steenhuysen J. CDC finds more clotting cases with J&J vaccine: sees causal link. Reuters May 12, 2021.
37 Shimabukuro T. Update: Thrombosis with thrombocytopenia syndrome (TTS) following COVID-19 vaccination. CDC May 12, 2021.
38 Oliver S. TTS Updates: Work Group Interpretation. CDC May 12, 2021.
39 Shimabukuro T. Update: Thrombosis with thrombocytopenia syndrome (TTS) following COVID-19 vaccination. CDC May 12, 2021.
40 Erman M, Steenhuysen J. CDC finds more clotting cases after J&J vaccine, sees causal link. The Wenatchee World May 12, 2021.
41 Oliver S. TTS Updates: Work Group Interpretation. CDC May 12, 2021.