PEP RCT with 749 tixagevimab/cilgavimab patients and 372 control patients, showing lower risk of symptomatic cases with treatment, without statistical significance. STORM CHASER. NCT04625972(history).Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, and BQ.1.1 Planas.
Abstract: FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE
AUTHORIZATION FOR EVUSHELD™ (tixagevimab co-packaged with cilgavimab)
HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA)
These highlights of the EUA do not include all the information
needed to use EVUSHELD™ under the EUA. See the FULL FACT
SHEET FOR HEALTHCARE PROVIDERS for EVUSHELD.
compromise and an inadequate immune response to COVID-19
vaccination, the justification for emergency use of drugs during the
COVID-19 pandemic, information on available alternatives, and
additional information on COVID-19. (1)
EVUSHELD (tixagevimab) injection; (cilgavimab) injection, copackaged for intramuscular use
Original EUA Authorized Date: 12/2021
------------------------DOSAGE AND ADMINISTRATION----------------------The dosage of EVUSHELD for emergency use is 150 mg of
tixagevimab and 150 mg of cilgavimab administered as two separate
consecutive intramuscular injections. See Full Fact Sheet for
Healthcare Providers for detail on preparation and administration. (2)
----------------------------------EUA FOR EVUSHELD----------------------------The U.S. Food and Drug Administration has issued an EUA for the
emergency use of the unapproved product EVUSHELD (tixagevimab
co-packaged with cilgavimab), SARS-CoV-2 spike protein-directed
attachment inhibitor, for the pre-exposure prophylaxis of coronavirus
disease 2019 (COVID-19) in adults and pediatric individuals (12 years
of age and older weighing at least 40 kg):
• Who are not currently infected with SARS-CoV-2 and who have not
had a known recent exposure to an individual infected with SARSCoV-2 and
• Who have moderate to severe immune compromise due to a
medical condition or receipt of immunosuppressive medications
or treatments and may not mount an adequate immune response
to COVID-19 vaccination or
• For whom vaccination with any available COVID-19 vaccine,
according to the approved or authorized schedule, is not
recommended due to a history of severe adverse reaction (e.g.,
severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID19 vaccine component(s).
EVUSHELD may only be prescribed for an individual patient by
physicians, advanced practice registered nurses, and physician
assistants that are licensed or authorized under state law to prescribe
drugs in the therapeutic class to which EVUSHELD belongs (i.e., antiinfectives).
EVUSHELD has been authorized by FDA for the emergency use
described above. EVUSHELD is not FDA-approved for any use,
including use for pre-exposure prophylaxis of COVID-19. (1)
EVUSHELD is authorized only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency use
of EVUSHELD under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.
LIMITATIONS OF AUTHORIZED USE
• EVUSHELD is not authorized for use in individuals:
o For treatment of COVID-19, or
o For post-exposure prophylaxis of COVID-19 in individuals who
have been exposed to someone infected with SARS-CoV-2.
• Pre-exposure prophylaxis with EVUSHELD is not a substitute for
vaccination in individuals for whom COVID-19 vaccination is
recommended. Individuals for whom COVID-19 vaccination is
recommended, including individuals with moderate to severe
immune compromise who may derive benefit from COVID-19
vaccination, should receive COVID-19 vaccination.
• In individuals who have received a COVID-19 vaccine, EVUSHELD
should be administered at least two weeks after..
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation. FLCCC and WCH
provide treatment protocols.