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    强生单剂量新冠肺炎疫苗获得欧盟委员会有条件

    21-03-19 作者:强生集团 来源:未知 点击:59

    参考文献

    1. Janssen. Johnson Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial. Available at:https://www.janssen.com/emea/sites/www_janssen_com_emea/files/johnson_johnson_announces_single-shot_janssen_covid-19_vaccine_candidate_met_primary_endpoints_in_interim_analysis_of_its_phase_3_ensemble_trial.pdf. Last accessed: March 2021.

    2. European Medicines Agency. EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU. Available at: https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-janssen-authorisation-eu. Last accessed: March 2021.

    3. Janssen. Johnson Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate. Available at:https://www.janssen.com/emea/sites/www_janssen_com_emea/files/johnson_johnson_announces_european_commission_approval_of_agreement_to_supply_200_million_doses_of_janssens_covid-19_vaccine_candidate.pdf. Last accessed: March 2021.

    4. Janssen. Johnson Johnson Announces Initiation of Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with the European Medicines. Available at:http://www.janssen.com/sites/www_janssen_com_emea/files/jj_announces_initiation_of_rolling_submission_for_its_single_dose_janssen_covid19_vaccine_candidate_with_the_ema.pdf. Last accessed: March 2021.

    5. Janssen. Johnson Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate. Available at:https://www.janssen.com/emea/sites/www_janssen_com_emea/files/jj_announces_submission_to_who_for_eul_of_investigational_single-shot_janssen_covid-19_vaccine_candidate_.pdf. Last accessed: March 2021.

    6. Johnson Johnson. Johnson Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic. Available at: https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic. Last accessed: March 2021.

    7. Johnson Johnson. Johnson Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee. Available at:https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-u-s-fda-advisory-committee. Last accessed: March 2021.

    8. Johnson Johnson. Johnson Johnson COVID-19 Vaccine Granted Authorization under Interim Order by Health Canada For Emergency Use. Available at: https://www.jnj.com/johnson-johnson-covid-19-vaccine-granted-authorization-under-interim-order-by-health-canada-for-emergency-use. Last accessed: March 2021.

    9. Summary of Product Characteristics. COVID-19 Vaccine Janssen suspension for injection. March 2021.

    10. Custers, J., Kim, D., et al. Vaccines based on replication incompetent Ad26 viral vectors: Standardized template with key considerations for a risk/benefit assessment. Vaccine. 2020.

    11. ClinicalTrials.gov. A study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE). Available at: https://clinicaltrials.gov/ct2/show/NCT04505722. Last accessed: March 2021.

    12. Johnson Johnson. COVID-19 Phase 3 study clinical protocol. Available at:https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protocol. Last accessed: March 2021.
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