Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine

. This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.

* The immunization schedule is two doses intramuscular injections (deltoid) with a 14-28 days interval.
* There will be 900 participants (300 health care professionals between 18 and 59 years old); 300 participants 75 years old or more; 300 participants between 60 and 74 years old. All participants must be allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Brazilian Immunization National Plan.
* For safety analysis , the incidence of adverse events after receiving the Adsorbed COVID-19 (inactivated) Vaccine that needed health assistance until 42 days after two-doses immunization schedule.
* The total period of participation in the study will be approximately 60 days after completing the two-dose schedule of the vaccine.
* Active pharmacovigilance studies are essential to assess the safety profile of the vaccine in subgroups that will be included as target populations in the Immunization Program.

• Adsorbed COVID-19 (Inactivated) Vaccine (Biological): Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute

Primary outcomes

• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions. [7 days after each dose of the vaccine]: Frequency of solicited and non-solicited local and systemic adverse reactions according to age group and severity.
• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group [7 days after each dose of the vaccine]: Frequency of participants who presented any solicited and non-solicited local and systemic adverse reactions according to age group and severity.

Secondary outcomes

• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which needed medical care in participants >= 18 years. [42 days after any dose of the vaccine]: Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity.
• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which required medical care in participants < 18 years. [365 days after the second dose of the vaccine.]: Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity.
• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions. [First 30 minutes after each dose of the vaccine.]: Frequency of solicited and non-solicited local and systemic adverse reactions according to the dose, severity and age group.
• Incidence of serious adverse event (AE) [The whole period of study (365 days after the second dose)]: Incidence of serious adverse event
• Description of medications used after adverse event (AE) [The whole period of study (365 days after the second dose)]: Description of medications and duration used after adverse event
• Incidence of adverse event of special interest (AESI) [The whole period of study (365 days after the second dose)]: Incidence of adverse event of special interest
• Incidence of serious adverse event if a subject get pregnant (SAE) [From the recrod of pregnancy until the end of the study or upto the birth.]: Incidence of serious adverse event if a subject get pregnant after received any dose of the vaccine

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Adult allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Immunization National Plan.
* Informed consent form signed by participant.
* Show voluntary intention to participate in the study and availability throughout the study.

Exclusion Criteria:

* History of severe allergic reactions or anaphylaxis to previous vaccines or allergy to any components of the study vaccine.
* History of fever (axillar temperature ≥ 37,8º C) 72 hours before the vaccine
* Be unavailable during the study period.
* Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.

• Marta H Lopes, MD, Principal investigator, University of Sao Paulo