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1. www.fda.gov › news-events › press-announcementsFDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 ...

   www.fda.gov › news-events › press-announcements

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   Sep 22, 2021 · Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be...

   • Coronavirus (COVID-19) Update: FDA Authorizes Additional ...

     The FDA evaluated information on the use of a third dose of...

   • Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to ...

     January 03, 2022. Español. Today, the U.S. Food and Drug...

2. www.cdc.gov › mmwr › volumesEffectiveness of Third Dose of Pfizer-BioNTech and Moderna ...

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   In a multistate network, adults vaccinated with 2 or 3 doses of a COVID-19 mRNA vaccine were protected against COVID-19–associated hospitalization. Significantly higher VE was observed in adults who received a third mRNA vaccine dose either as part of a primary vaccine series (immunocompromised persons) or as a booster dose (immunocompetent persons) compared with those who had received 2 doses. These findings underscore the importance of immunocompromised adults obtaining a third mRNA vaccine dose ≥28 days after the second vaccine dose and of immunocompetent adults receiving a third (booster) dose currently recommended ≥5 months after the second dose.§§

   This study was conducted during a period of SARS-CoV-2 Delta variant predominance (8). VE against the B.1.1.529 (Omicron) variant of SARS-CoV-2 might be lower than for other variants that have circulated widely, possibly because of immune evasion. Early evidence suggests that a third mRNA vaccine dose elicits markedly stronger neutralizing antibody responses to the Omicron variant compared with responses to 2 vaccine doses (9), and increases VE against severe disease following infection with the Omicron variant (10). The effectiveness of 3 doses of COVID-19 mRNA vaccines against a range of disease severity associated with the Omicron variant needs to be carefully evaluated in different populations.

   The findings in this report are subject to at least six limitations. First, 2-dose and 3-dose vaccine recipients were similar in terms of most demographic and clinical characteristics but might have differed with respect to exposure risk for SARS-CoV-2 infection or risk factors for severe COVID-19. Therefore, residual or unmeasured confounding was possible. Second, VE associated with newly emergent variants, including Omicron, was not assessed. Third, VE was not assessed against SARS-CoV-2 infection or mild illness. Fourth, most 3-dose mRNA vaccine recipients were vaccinated within several weeks of enrollment and durability of protection will require future analysis. Fifth, VE associated with a fourth mRNA vaccine dose, recommended as a booster dose in immunocompromised individuals ≥5 months after dose 3, was not assessed. Finally, although medical centers in 18 states were included in the analysis, patients might not be representative of the general U.S. population.

   Among adults with and without immunocompromising conditions who were eligible to receive a third dose of COVID-19 mRNA vaccine, third doses were found to increase protection beyond that of a 2-dose vaccination series for the prevention of COVID-19 hospitalization. Administration of a third COVID-19 mRNA vaccine dose as part of a primary series among immunocompromised adults, or as a booster dose among immunocompetent adults, provides improved protection against COVID-19 hospitalization.

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   1.Thompson MG, Stenehjem E, Grannis S, et al. Effectiveness of COVID-19 vaccines in ambulatory and inpatient care settings. N Engl J Med 2021;385:1355–71. Epub September 8, 2021. https://doi.org/10.1056/NEJMoa2110362external icon PMID:34496194external icon

   2.Tenforde MW, Self WH, Adams K, et al.; Influenza and Other Viruses in the Acutely Ill (IVY) Network. Association between mRNA vaccination and COVID-19 hospitalization and disease severity. JAMA 2021;326:2043–54. https://doi.org/10.1001/jama.2021.19499external icon PMID:34734975external icon

   3.Tartof SY, Slezak JM, Fischer H, et al. Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study. Lancet 2021;398:1407–16. https://doi.org/10.1016/S0140-6736(21)02183-8external icon PMID:34619098external icon

   4.Food and Drug Administration. Coronavirus (COVID-19) update: FDA takes multiple actions to expand use of Pfizer-BioNtech COVID-19 vaccine. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccineexternal icon

   5.Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes additional vaccine dose for certain immunocompromised individuals. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromisedexternal icon.

   6.Food and Drug Administration. Coronavirus (COVID-19) update: FDA expands eligibility for COVID-19 vaccine boosters. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-covid-19-vaccine-boostersexternal icon.

   See full list on cdc.gov

3. www.cnn.com › 2021/08/14 › healthA third dose of Covid-19 vaccine is now authorized for some ...

   www.cnn.com › 2021/08/14 › health

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   Aug 14, 2021 · The US Food and Drug Administration on Thursday authorized third doses of both the Pfizer/BioNTech or Moderna coronavirus vaccines for certain immunocompromised people: solid organ...

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4. www.cdc.gov › media › releasesCDC Recommends Pfizer Booster at 5 Months, Additional Primary ...

   www.cdc.gov › media › releases

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   Jan 4, 2022 · (404) 639-3286. Today, CDC is updating our recommendation for when many people can receive a booster shot, shortening the interval from 6 months to 5 months for people who received the Pfizer-BioNTech COVID-19 Vaccine. This means that people can now receive an mRNA booster shot 5 months after completing their Pfizer-BioNTech primary series.

5. edition.cnn.com › 2021/07/28 › healthPfizer data suggest third dose of Covid-19 vaccine ‘strongly ...

   edition.cnn.com › 2021/07/28 › health

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   Jul 28, 2021 · CNN — A third dose of the Pfizer/BioNTech Covid-19 vaccine can “strongly” boost protection against the Delta variant – beyond the protection afforded by the standard two doses, new data...