Vaccine Preventable Diseases

Coronavirus 2019 (COVID-19)

ACIP Recs | Disease | Vaccine | References | VIS

Children and Adolescents
• All children and adolescents without contraindications 5-17 years of age should receive 2 doses of Pfizer-BioNTech COVID-19 vaccine (trade name: Comirnaty®) administered 3 weeks apart [5, 6].
• Children and adolescents who received 2 doses of Pfizer-BioNTech or Moderna vaccine who have moderately to severely compromised immune systems should receive a third primary series dose a minimum of 28 days after the second dose [16].
• Adolescents 12-17 years of age who received a primary series of Pfizer-BioNTech COVID-19 vaccine should receive a booster dose of Pfizer-BioNTech COVID-19 vaccine a minimum of 5 months after the previous dose [27].

Adults
• All adults without contraindications should receive a primary COVID-19 vaccine series comprising either: 2 doses of Pfizer-BioNTech COVID-19 vaccine (trade name: Comirnaty®) administered 3 weeks apart [31], 2 doses of Moderna COVID-19 vaccine administered 4 weeks apart [32], or 1 dose of Janssen (Johnson & Johnson) COVID-19 vaccine [33].
o mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccines are preferred over J&J COVID-19 vaccine [34, 35].
• Adults who received 2 doses of Pfizer-BioNTech or Moderna vaccine who have moderately to severely compromised immune systems should receive a third primary series dose a minimum of 28 days after the second dose [16].
• All adults who received 1 dose of J&J COVID-19 vaccine should receive a booster dose (of whichever COVID-19 vaccine they prefer) a minimum of 2 months after the initial dose [27].
• Adults who received a primary series of Pfizer-BioNTech or Moderna COVID-19 vaccine should receive a booster dose (of whichever COVID-19 vaccine they prefer) a minimum of 5 months after the previous dose [27].

For More Information
ACIP recommendations:  https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html
Immunization schedules: http://www.cdc.gov/vaccines/schedules/index.html

COVID-19 is caused by the SARS-CoV-2 virus, a type of coronavirus that began spreading in humans in 2019. SARS-CoV-2 generally enters the body through the mouth or nose via small liquid particles (ranging from larger respiratory droplets to smaller aerosols). Prevention measures other than vaccination include avoiding poorly ventilated public indoor spaces, keeping at least 6 feet of separation from others, and wearing a mask when separation from others is not feasible. The incubation period of COVID-19 averages 5-6 days and ranges 2-14 days. Most infected persons experience mild to moderate respiratory illness and recover without medical intervention. However, some infected persons develop severe illness and require medical attention to mitigate risk of serious complications or death. Severe illness and death occur in persons of all ages but is much more common among older adults as well as those with underlying medical conditions such as cancer, cardiovascular disease, chronic respiratory disease, or diabetes. The most common symptoms of COVID-19 are fever, cough, fatigue, and sudden olfactory dysfunction or anosmia (loss of smell/taste). Other less, but still relatively common, symptoms include sore throat, headache, body ache, and diarrhea. Symptoms indicating a need for emergency medical attention include difficulty breathing or shortness of breath, chest pain/pressure, loss of speech/mobility or increase in confusion, or discoloration (e.g. pale, grey, blue) of skin or nail beds of fingers/toes. [5,6]

Three COVID-19 vaccines are authorized in the United States: two messenger ribonucleic acid (mRNA) vaccines (Pfizer-BioNTech and Moderna) and one viral vector vaccine (J&J).

Although these are the first mRNA vaccines authorized for public use, the technology behind the mRNA vaccines has been studied and developed for years. This prior work allowed mRNA vaccines specific to COVID-19 to be created very quickly once the genome of the SARS-CoV-2 virus was determined. The injected mRNA uses a person’s own cells to produce the spike protein from the virus, stimulating an antibody response that provides protection against natural infection. mRNA does not enter the nucleus of cells and is broken down quickly [8].

The J&J vaccine is a non-replicating adenovirus type 26-vectored vaccine. Viral vector technology has been well studied and used for other vaccines such as Ebola. In viral vector vaccines, a modified virus is used as a vector to deliver a specific gene to a person’s cells that instructs the cells to produce the target protein (the COVID-19 spike protein), stimulating antibody response and protection against disease. This is not considered a live vaccine. Although the vector delivers information to human cells, the virus does not replicate [14].

Emergency Use Authorization and Accelerated Timeline
The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for both mRNA COVID-19 vaccines in December 2020; first the Pfizer-BioNTech vaccine (for ages 16 and older) [15], followed by the Moderna vaccine (for ages 18 and older) [15]. The FDA issued EUA for the J&J vaccine (for ages 18 and older) in February 2021 [17]. The FDA expanded the EUA for the Pfizer-BioNTech vaccine to include adolescents 12-16 years of age in May 2021 [18]. The Pfizer-BioNTech vaccine (trade name: Comirnaty®) was fully approved by the FDA in August 2021 for persons at least 16 years of age [19]. The FDA expanded the EUA for the Pfizer-BioNTech vaccine to include children at least 5 years of age in October 2021 [20]. The Moderna vaccine (trade name: Spikevax®) was fully approved by the FDA in January 2022 for persons at least 18 years of age [21].

Many factors contributed to the unprecedentedly rapid development, testing, and authorization of COVID-19 vaccine candidates. Some of these factors include combining clinical phases, rapid accumulation of assessable cases due to the high rate of disease and reduction of financial risk to manufacturers. The FDA maintains rigorous standards for vaccine efficacy and safety for both EUA and final complete approval. The risk of moving at a rapid pace for EUA has been mainly financial; if a vaccine candidate is found not to meet safety and efficacy standards at any point, it is discontinued and the money invested to conduct these trials and create the manufacturing capacity for the vaccine ahead of time is lost. This financial risk has largely been taken on by governments and manufacturers. Supporting the development of multiple vaccine candidates increases the chances that some vaccine candidates will prove to be very safe and effective and will be manufactured at scale in time to make a difference in the fight against this ongoing pandemic [22,23].

Dosing Schedule
The Pfizer-BioNTech vaccine requires a two-dose (0.3 mL each for adolescents and adults; 0.2 mL each for children) primary series with 3 weeks between doses [1,2,9]. The Moderna vaccine requires a two-dose (0.5 mL each) primary series with 4 weeks between doses [10]. However, there is no maximum interval between the first and second dose for either vaccine, so delays between doses due should not interfere with administration of the second dose once ready. The J&J vaccine requires a one-dose (0.5mL) primary series with a booster at least two months after the initial dose [4,11]. A booster dose should be given a minimum of 5 months after the previous dose to persons who received the primary series of Pfizer-BioNTech or Moderna vaccine. Booster doses use the same amounts as primary series doses except for Moderna, which uses a half dose (0.25 mL) for the booster. Booster doses do not need to be the same brand as the primary series and can be chosen based on preference and availability, though mRNA vaccines are preferred to J&J, and adolescents are only eligible to receive Pfizer-BioNTech [4]. Moderately to severely immunocompromised people who received a primary series of Pfizer-BioNTech or Moderna vaccine should receive a third primary series dose of the same mRNA vaccine at least four weeks after their second dose, and a booster dose at least 3 months after their third primary series dose; moderately to severely immunocompromised people who received a J&J vaccine should receive an additional dose with an mRNA vaccine at least 4 weeks after, as well as an mRNA booster at least two months after the additional dose [7]. Adults 50 years of age or older and moderately to severely immunocompromised people may receive a second mRNA booster dose a minimum of 4 months after the previous booster dose [4,7].

Vaccine Effectiveness:
The Pfizer-BioNTech vaccine prevented COVID-19 with 95% efficacy (95%CI: 90.3-97.6) in its phase III clinical trial starting one week after the second dose (among participants over 16 years of age without prior evidence of natural infection). Efficacy remained at least 94% when including participants with prior infection. Efficacy was consistent across demographic subgroups. One severe case of COVID-19 occurred in the vaccine group compared to 4 in the placebo group [24]. Among a subset of adolescents 12-15 years of age, the Pfizer-BioNTech vaccine produced a greater immune response than among young adults (16-25 years of age) and prevented COVID-19 with 100% efficacy [92]. Among children 5-11 years of age, the Pfizer-BioNTech vaccine prevented COVID-19 with 90.7% efficacy (95%CI: 67.7%-98.3%) [26].

The Moderna vaccine prevented COVID-19 with 94.5% efficacy (95%CI: 86.5%-97.8%) in its phase III clinical trial starting two weeks after the second dose (among adults without prior evidence of natural infection). Efficacy remained at least 93% when including participants with prior infection. Efficacy was consistent across demographic subgroups. All 11 severe cases of COVID-19 occurred in the placebo group [27].

The J&J vaccine prevented moderate to severe COVID-19 with 67% efficacy (95%CI: 59.0-73.4) among adults in its phase III clinical trial starting two weeks after vaccination. Efficacy was consistent across demographic subgroups (e.g., age, comorbidity, race, ethnicity). As of February 5, 2021, 7 COVID-19 related deaths occurred in the placebo group compared to 0 in the vaccine group [28].

Real-world data support the effectiveness of vaccines against COVID-19 infection, symptoms, hospitalization, and death. In a prospective cohort of nearly 4,000 health care personnel tested weekly for 13 weeks through March 2021, full immunization (≥14 days after dose 2) was 90% effective against infection (95%CI: 68-97), and partial immunization (≥14 days after dose 1 but before dose 2) was 80% effective against infection (95%CI: 59-90), regardless of symptoms [29]. In a multisite test-negative study among health care personnel through March 2021, full immunization was 94% effective against symptomatic disease, and partial immunization was 82% effective against symptomatic disease [30]. In a retrospective case-control study of more than 136,000 individuals in five states between December 2020 and April 2021, at least one dose of Pfizer-BioNTech or Moderna vaccine was 86% and 93% effective against infection, respectively, and both vaccines were 100% effective in preventing COVID-19-associated intensive care unit (ICU) admission [31]. The effectiveness of J&J vaccine against COVID-19 infection and hospitalization is lower than the effectiveness of either mRNA vaccine, though still impactful [32].

The effectiveness of COVID-19 vaccines against infection slowly declines over time and are also somewhat less effective against infection with some newer variants (such as Delta and Omicron) compared to the original strain. However, COVID-19 vaccines still greatly reduce the risk of infection and remain highly effective at preventing severe disease and death [33,34], provided persons stay up to date with recommended booster doses .

Vaccine Safety
Common side effects from Pfizer-BioNTech vaccine among participants in its phase III clinical trial over 16 years of age included: injection site reactions (e.g., pain, redness, swelling) (84%), fatigue (63%), headache (55%), muscle pain (38%), chills (32%), joint pain (24%), and fever (14%). The vast majority of these were mild to moderate, resolving within a couple of days after onset. Systemic effects were more common and severe after the second dose compared to the first, with the most frequent "severe" side effects of the second dose being fatigue (5%), headache (3%), chills (2%), and muscle pain (2%). Most of these effects were less common and milder among older adults compared to younger adults. Among adverse events of special interest (AESIs) which could possibly be related to vaccination, lymphadenopathy (axillary swelling and tenderness of the vaccination arm) was reported in 64 vaccine recipients (0.3%) compared to only 6 (<0.1%) in the placebo group, lasting 10 days on average. Bell’s palsy was reported in four vaccine recipients (<0.1%) and none in placebo recipients. The observed rate is consistent with the expected background rate in the general population, and there was no time clustering to suggest a causal relationship. No other notable patterns that would suggest a causal relationship were noted by the FDA. This includes deaths, of which 2 were reported among vaccine recipients and 4 among placebo recipients, numbers consistent with the expected background rate in the general population for these age groups [24]. Rates of common side effects among adolescents 12-15 years of age were similar to rates among young adults (16-25 years of age), and no vaccine-related serious adverse events occurred among adolescents 12-15 years of age [25]. Among children 5-11 years of age, some injection site reactions (e.g., redness, swelling) were higher than among young adults, but rates of systemic reactions (e.g., fever) were lower than among young adults, reactogenicity was mostly mild to moderate and quickly resolving, and no vaccine-related serious adverse events occurred [2,26,35].

Common side effects from Moderna vaccine in its phase III clinical trial included: injection site pain (92%), fatigue (69%), headache (63%), muscle pain (60%), joint pain (45%), chills (43%), and fever (15%). The vast majority of these were mild to moderate. Systemic effects were more common and severe after the second dose compared to the first, with the most frequent "severe" side effects of the second dose being fatigue (10%), headache (6%), muscle pain (9%), joint pain (5%), and chills (1%). However, most of these effects were less common and milder among older adults compared to younger adults. Among adverse events of special interest (AESIs) which could possibly be related to vaccination, lymphadenopathy was reported in 173 vaccine recipients (1.1%) compared to 95 (0.6%) in the placebo group. Bell’s palsy was reported by three vaccine recipients and one placebo recipient; the low frequency was consistent with the expected background rate in the general population. Hypersensitivity wase reported in 1.5% of vaccine recipients compared to 1.1% of placebo recipients; however, no episodes of anaphylaxis or severe hypersensitivity had close temporal relation to the vaccine. Three vaccine recipients with dermal fillers reported swelling at the site of the fillers after vaccination; two of these were reported as serious adverse events (SAEs), but all resolved over time. No other notable patterns that would suggest a causal relationship were noted by the FDA. This includes deaths, of which 6 were reported among vaccine recipients and 7 among placebo recipients, numbers consistent with the expected background rate in the general population for these age groups [27].

Common side effects from J&J vaccine in its phase III clinical trial included: injection site pain (49%), headache (39%), fatigue (38%), muscle pain (33%), nausea (14%), and fever (9%). The vast majority of these were mild to moderate, resolving within a couple of days after onset. Adverse events with numerical imbalances between groups included: urticaria (hives), which was reported in 5 vaccine recipients compared to 1 in the placebo group; thromboembolic events, which were reported in 15 vaccine recipients compared to 10 in the placebo group; and tinnitus, which was reported in 6 vaccine recipients compared to none in the placebo group. These data are insufficient to determine causality. No other notable patterns that would suggest a causal relationship were noted by the FDA. This includes deaths; 5 were reported among vaccine recipients and 20 among placebo recipients as of February 5, 2021 [28].

Rarely, allergic reactions occur after COVID-19 vaccination due to hypersensitivity to a vaccine component such as polyethelene glycol (PEG) [36]. PEG can be found in osmotic laxatives and oral bowel preparations for colonoscopy procedures, among other medications. Cross-reactive hypersensitivity between PEG and polysorbates may also occur. Polysorbates can be found in many licensed vaccines, as well as some injectable drugs (e.g., corticosteroids), biological agents and monoclonal antibodies. Higher than expected rates of anaphylaxis following the Pfizer-BioNTech (~4.7 cases per million doses) and Moderna (~2.5 cases per million doses) COVID-19 vaccines have been identified [37], as compared to ~1 case per million doses for most other vaccines [38]. The CDC provides guidance for screening to detect individuals who might be at risk, managing allergic reactions, and recommendations for those who experience an allergic reaction after receiving a COVID-19 vaccine or have a history of allergic reactions. Personnel at all sites administering these (and other) vaccines should be prepared to promptly treat individuals who develop allergic reactions. All vaccine recipients should be observed for at least 15 minutes after vaccination to safeguard against potential allergic reactions; persons with a history of anaphylaxis should be observed for at least 30 minutes [39]. See the Contraindications and Precautions section as well as the Do Vaccines Cause Hypersensitivity Reactions? summary for more details.

mRNA COVID-19 vaccination has been associated with rare cases of myocarditis and pericarditis, mostly among young males after the second dose. Of over 2.5 million persons receiving the Pfizer-BioNTech vaccine in Israel, 54 cases of myocarditis were identified, most of which were mild or moderate in severity; the rate of myocarditis was highest among males 16-29 years of age (11 per 100,000 vaccinated persons) [40]. Of over 400,000 adolescents 12-15 years of age receiving the Pfizer-BioNTech vaccine in Israel, 13 cases of myocarditis were identified, all of which were mild in severity; the rate of myocarditis after the second dose was 8 per 100,000 adolescents 12-15 years of age [41]. Data from the US Vaccine Safety Datalink (VSD) as of October 23, 2021, estimated a rate of 11 per 100,000 second doses of Pfizer-BioNTech vaccine among adolescent males 12-15 years of age, and suggested double the risk of myocarditis after Moderna versus Pfizer-BioNTech vaccine. See the Do Vaccines Cause Myocarditis Or Myocardopathy/Cardiomyopathy? summary for more details.

J&J vaccination has been associated with very rare cases of thrombosis with thrombocytopenia syndrome (TTS). TTS is a serious condition involving blood clots with low platelets and has mostly occurred in women 30-49 years of age. The FDA and CDC paused J&J vaccination on April 13, 2021 after 6 cases of TTS were reported to the US passive safety monitoring system Vaccine Adverse Event Reporting System (VAERS) so that these cases could be investigated further. The pause was ultimately lifted on April 23, 2021, by which time the total cases reported to VAERS had grown to 15, as the ACIP determined that the benefits of vaccination outweighed the risks due to the rarity of TTS and the risks of COVID-19 [42,43]. However, young women may wish to choose an mRNA COVID-19 vaccine to avoid the small risk of TTS. As of December 16, 2021, 54 cases of TTS (37 in females and 17 in males) and 8 TTS-related deaths have been confirmed following J&J vaccination (out of 14.1 million doses administered). See the Do Vaccines Cause Thrombocytopenia or Immune Thrombocytopenic Purpura?summary for more details.

J&J vaccination may also be associated with very rare cases of Guillain-Barré Syndrome (GBS). Data from the VSD, as of November 13, 2021, estimated an unadjusted incidence rate of 34.6 confirmed cases of GBS per 100,000 person-years within 21 days after J&J vaccination (95%CI: 15.8-65.7), significantly higher than the background rate, and an adjusted risk ratio (versus 22-42 days after vaccination) of 6.03 (95% CI: 0.79-147.79). See the Do Vaccines Cause Guillain-Barré Syndrome? summary for more details.

Other rare adverse events identified in an evaluation of data from over 2.4 million persons receiving the Pfizer-BioNTech vaccine in Israel included lymphadenopathy (with an excess risk of 78.4 events per 100,000 persons), herpes zoster (with an excess risk of 15.8 events per 100,000 persons), and appendicitis (with an excess risk of 5.0 events per 100,000 persons) [44]. See the Do Vaccines Cause Herpes Zoster? summary for more details.

COVID-19 vaccines cannot cause COVID-19 infection or disease as the SARS-CoV-2 virus is not contained in the vaccines. COVID-19 vaccines also cannot affect DNA [8,14].

Contraindications and Precautions
A history of immediate allergic reaction of any severity to a COVID-19 vaccine, or to any component of a COVID-19 vaccine is a contraindication to receive additional doses of the vaccine. Persons with known allergic reactions to polyethylene glycol (PEG) should not receive the mRNA vaccines. Polysorbate, which is contained in the J&J vaccine, has the potential for cross-reactive hypersensitivity with PEG.

Persons who had allergic reactions that were not severe may be able to receive a COVID-19 vaccine after evaluation by an allergist-immunologist. Those with a contraindication to mRNA COVID-19 vaccines automatically have a precaution to J&J COVID-19 vaccine, and vice versa. Persons who received one mRNA COVID-19 dose but are contraindicated to receive the second dose may receive J&J COVID-19 vaccine at least 28 days after the mRNA vaccination, under the supervision of a health care provider experienced in the management of severe allergic reactions.

A history of severe allergic reaction (e.g., anaphylaxis) to any other vaccine or injectable therapy is a precaution to COVID-19 vaccination; persons with such a history may be vaccinated but should be counseled about the potential risks before and observed for 30 minutes after vaccination. Moderate or severe acute illness is also a precaution to COVID-19 vaccination; such persons should be counseled about the potential risks and observed for 15 minutes after vaccine administration.

Those with a history of mild allergic reaction to a vaccine or a history of allergic reactions (including severe allergic reactions) unrelated to vaccines, PEG, and polysorbate may proceed with COVID-19 vaccination. There are currently no other contraindications or precautions to COVID-19 vaccination including immunocompromising conditions, pregnancy, and lactation. These recommendations may change as further information becomes available and will be updated on the CDC website accordingly [3].

Considerations in Pregnancy
Pregnant women should be vaccinated against COVID-19.

Initially, only limited data on vaccine efficacy and safety were available among pregnant and breastfeeding women, as they were excluded from clinical trials. The manufacturers conducted Developmental and Reproductive Toxicity (DART) studies in animals and identified no safety signals [45].

Early data on the efficacy of mRNA COVID-19 vaccines during pregnancy are promising. Immune responses among pregnant women appear similar to non-pregnant women, and vaccine-generated antibodies transferred to unborn infants via the umbilical cord and recently born infants via breastmilk [46]. Effectiveness of the Pfizer-BioNTech vaccine among pregnant women appears high and comparable to the general population [47,48].

Early data on the safety of mRNA COVID-19 vaccines during pregnancy are reassuring; no obvious signals have arisen in safety monitoring for pregnant women or their babies [49], and active case-control surveillance found no link between vaccination and spontaneous abortion [50].

The available COVID-19 vaccines are not live vaccines and the theoretical risks are minimal. COVID-19 vaccines help protect pregnant women and their unborn children from COVID-19. Thus, the American College of Obstetricians and Gynecologists (ACOG) has recommended that all pregnant and lactating individuals be vaccinated against COVID-19 [51]. Pregnancy registries have been established to monitor the outcomes of women pregnant at the time of vaccination [52,53].

References

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