Should patients avoid pain relievers before the COVID-19 vaccine?

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Great strides have been made in understanding, preventing and treating serious COVID-19 infections.

The FDA’s emergency use clearance for available COVID-19 vaccines and the recent full FDA approval of the Pfizer COVID-19 vaccine were monumental moments in the fight against this relentless virus. As the COVID-19 pandemic persists, pharmacists continue to play a critical role in providing patients with reliable information on the prevention, detection, treatment and management of COVID-19. Pharmacists can be influential in dispelling misinformation and common myths about the COVID-19 virus, its variants, and available vaccines. At the onset of the pandemic, there were initial concerns about the safety of people with COVID-19 taking ibuprofen, but those claims came from anecdotal, low-quality evidence.1 Leading public health organizations around the world do not recommend against using ibuprofen to relieve symptoms of COVID-19 or adverse reactions (AEs) associated with the vaccine.1 As accessible healthcare providers, pharmacists are likely to encounter patients seeking advice on the use of over-the-counter pain relievers / antipyretics, such as acetaminophen, and nonsteroidal anti-inflammatory agents (NSAIDs). ), such as ibuprofen and naproxen sodium, for symptoms relief of some of the common mild to moderate symptoms associated with COVID-19 that may lend themselves to self-treatment and management of AEs, such as fever and pain, associated with COVID-19 vaccines.

In a recent post on the Medical News Today website, the author indicates that the CDC recommends consulting a healthcare professional about taking pain relievers / fever reducers to manage AEs from the COVID-19 vaccine.1

The CDC said: “It is not recommended that you take over-the-counter medications, such as ibuprofen, aspirin, or acetaminophen, before vaccination in an attempt to prevent side effects associated with the. vaccine. It is not known how these drugs could affect the effectiveness of the vaccine. However, if you are taking these medicines regularly for other reasons, you should continue to take them before you get the vaccine. It is also not recommended to take antihistamines before getting vaccinated against COVID-19 to try to prevent allergic reactions. “2

In response to early concerns about the use of NSAIDs and to evolving information on these issues, GlaxoSmithKline (GSK), a leading manufacturer of over-the-counter pain relievers, has released a statement on the use of ibuprofen and COVID-19 vaccines, stating: “The appropriate use of antipyretics / pain relievers, such as Advil (ibuprofen), is recommended by public health authorities to help relieve symptoms that may occur after vaccination.3-5 This is consistent with the fact that in studies of the COVID-19 vaccine, participants were allowed to use antipyretics / pain relievers to treat symptoms. “5

Additionally, GSK posted information on its Advil product website on a patient education initiative called #AfterMyShot, which provides patients with valuable information about COVID-19 and vaccines.6

On August 12, 2021, manufacturer Janssen also released a statement on the use of antipyretics and pain relievers and the COVID-19 vaccine. In its response, the manufacturer stated the following:7

  • Pre-vaccination: There is no strong clinical data on how the use of antipyretics before treatment affects the antibody responses induced by the COVID-19 vaccine.7
  • Post-vaccination: There is no clinical evidence that the use of antipyretics after vaccination has a negative effect on the efficacy of the COVID-19 vaccine.7
  • During the Janssen COVID-19 Vaccine clinical trial program, antipyretics were recommended after vaccination to relieve symptoms if needed. Prophylactic use of antipyretics was not encouraged. However, in some cases it could have been considered for participants with special circumstances and / or co-morbidities.7.8

Bayer Consumer Health, the maker of the over-the-counter NSAID marketed as Aleve, also has information on its website regarding the COVID-19 virus and the use of the product, stating: “To date, Public health authorities, including the Centers for Disease Control and Prevention, the United States Food and Drug Administration, the European Medicines Agency, and the World Health Organization, are not aware of any scientific evidence to support a link between the use of nonsteroidal anti-inflammatory drugs (NSAIDs), such as Aleve, and worsening COVID-19 results. “9

CLINICAL STUDIES

The available clinical evidence for other vaccines indicates that analgesics / fever reducers are commonly used at the time of vaccination to alleviate fever and pain, and use is primarily post-vaccination.10-12 Although the results of several studies show that prophylactic administration of analgesics / antipyretics decreases post-vaccination adverse effects, there are also results from studies showing that their use may decrease antibody responses to several vaccine antigens.13

In a recent publication from 2021, Etminan et al, reported that several regulatory agencies have made statements regarding the use of antipyretics at the time of vaccination. In 2015, the World Health Organization said that the use of antipyretics is not recommended before or at the time of vaccination but approved within days of vaccination, and the CDC agrees with those recommendations.14.15 Etminan et al, noted that to date, there is no clinical data on this issue with respect to COVID-19 vaccines, and data provided in clinical trials for mRNA vaccines only mentioned that the use of antipyretics increased with increasing dose concentrations. and dose number, but immunogenicity data was not provided.14.16.17 Finally, Etminan et al, indicated that in the future, clinical trials must urgently investigate and answer 4 questions: 14

  • Does acetaminophen or ibuprofen affect the antibody response of COVID-19 vaccines, and if so, is there a difference in antibody titers between the 2 agents?
  • Does a potential interaction with antipyretics vary between different types of vaccines (mRNA vaccines vs vaccines without mRNA)?
  • Does the timing of administration of antipyretics (before vaccination or immediately after) affect antibody titers?
  • Does any negative interaction only affect antibody titers for the first dose, second dose, or both? 14

Conclusion

As clinicians and patient educators, pharmacists can educate patients about the benefits of vaccines and provide patients with facts and dispel common myths and misconceptions about vaccines, especially the COVID-19 vaccine. Until more clinical data becomes available, patients should be urged to adhere to CDC recommendations and, when in doubt, should consult their primary health care providers before taking any medications, including medications. on sale.

Yvette C Terrie, BSPharm, RPh, is a consulting pharmacist and medical writer in Haymarket, Virginia.

THE REFERENCES

  1. Kandola A. Ibuprofen and COVID-19: is it safe? Medical news today. August 17, 2021. Accessed August 26, 2021. https://www.medicalnewstoday.com/articles/ibuprofen-and-covid
  2. Preparing for your COVID-19 vaccination. CDC. Updated August 19, 2021. Accessed August 26, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/prepare-for-vaccination.html
  3. Possible side effects after receiving a COVID-19 vaccine. CDC. Updated August 6, 2021. Accessed August 26, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html.
  4. Vaccines against the coronavirus (COVID-19). UK National Health Service. Revised August 19, 2021. Accessed August 26, 2021. https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/
  5. The Facts About Ibuprofen and COVID-19. GSK. Accessed August 26, 2021. https://www.gskhealthpartner.com/en-us/pain-relief/brands/advil/covid19/
  6. #AfterMyShot: what will you do? Advil. Accessed August 26, 2021. https://www.advil.com/coronavirus/vaccination/
  7. Janssen COVID-19 vaccine. Janssen MD. Updated August 27, 2021. Accessed August 31, 2021. https://www.janssenmd.com/janssen-covid19-vaccine/clinical-use/concomitant-use/antipyretics/janssen-covid19-vaccine-use-of-janssen-covid19-vaccine-with-antipyretics-and-analgesics
  8. Janssen & Prevention BV vaccines. Janssen. December 14, 2020. Accessed August 26, 2021. https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protocol
  9. Aleve and COVID-19. Raised. Accessed August 26, 2021. https://www.aleve.com/aleve-and-covid-19
  10. Saleh E, Moody MA, Walter EB. Effect of antipyretic analgesics on immune responses to vaccination. Hum Vaccine Immunother. 2016; 12 (9): 2391-2402. doi: 10.1080 / 21645515.2016.1183077
  11. Taddio A, Manley J, Potash L, Ipp M, Sgro M, Shah V. Routine immunization practices: use of topical anesthetics and oral analgesics. Pediatrics. 2007; 120 (3): e637-643. doi: 10.1542 / peds.2006-3351
  12. Manley J, Taddio A. Acetaminophen and ibuprofen for the prevention of adverse reactions associated with childhood immunization. Ann Pharmacother. 2007; 41: 1227-1232; doi: 1.1345 / aph.1H647
  13. Das RR, Panigrahi I, Naik SS. The effect of prophylactic antipyretic administration on post-vaccination adverse reactions and antibody response in children: a systematic review. PLoS A. 2014; 9 (9): e106629. doi: 10.1371 / journal.pone.0106629
  14. Etminan M, Sodhi M, Ganjizadeh-Zavareh S. Should antipyretics be used to relieve acute adverse events associated with COVID-19 vaccines? Chest. 2021; 159 (6): 2171-2172. doi: 10.1016 / j.chest.2021.01.080
  15. ACIP vaccine recommendations and guidelines. CDC. Updated May 4, 2021. Accessed August 26, 2021. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/administration.html
  16. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 Covid-19 mRNA vaccine. N Engl J Med. 2020; 383 (27): 2603-2615. doi: 10.1056 / NEJMoa2034577
  17. Baden LR, El Sahly MH, Essink B, et al. Efficacy and safety of mRNA-1273 SARS-CoV-2 vaccine. N English J Med. 2021; 384 (5): 403-416. doi: 10.1056 / NEJMoa203538
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