CME INDIA Presentation by Admin.
If you took after 4 weeks, nothing to worry.
- The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation
(AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis, 22.03.2021)
Safety and Efficacy
- Data on 32,449 participants accruing 141 symptomatic cases of COVID-19.
- Vaccine efficacy was consistent across ethnicity and age.
- Even in participants aged 65 years and over, vaccine efficacy was 80%.
- The vaccine was well tolerated
- No safety concerns related to the vaccine.
- No increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine.
This trial had only 4% Asians, 20% above 65 years and 60% with co-morbidities
- Amongst participants 79% were white/Caucasian, 8% black/African American, 4% native American and 4% Asian, and 22% of participants were Hispanic.
- Approximately 20% of participants were 65 years and over
- Approximately 60% had co-morbidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity or cardiac disease.
Four weeks Interval works well
- Previous trials have shown that an extended interval of up to 12 weeks demonstrated greater efficacy, which was also supported by immunogenicity data.
- This evidence suggests administration of the second dose with an interval longer than four weeks could further increase efficacy and accelerates the number of people who can receive their first dose.
Govt of India revises the schedule on 22.03.2021
- Protection enhanced if the second dose of COVISHIELD is administered between 6-8 weeks
- The recommendation has been revised to provide 2nd dose of COVISHIELD at 4-8 weeks’ interval after the 1st dose, instead of earlier practiced interval of 4-6 weeks.
- This decision of revised time interval between two doses is applicable ONLY to COVISHIELD and NOT to COVAXIN Vaccine.
- Keeping the existing scientific evidence in view, it appears that protection is enhanced if the second dose of COVISHIELD is administered between 6-8 weeks, but not later than stipulated period of 8 weeks.
What if you have taken already 2nd dose at 4 weeks interval?
Concern is this. Do you have an answer?
- Dr H D Sharan Ranchi: Get your antibody level tested. I have had good response but a doctor known to me, only had 2.5 U/ml. What should people like her do now?
- Dr Rajeev Jayadevan, Gastroenterotogist, Cochin: No need to routinely check antibodies after vaccine” is the main message. It is a fascinating science.
- Dr Anand Malani MD, Sangli: Is it about cell mediated immunity? Does good antibody response translate into good protection? The reverse may not be true due to unmeasured cell mediated immunity.
- CME INDIA story on 07/03/2021 answers it.
CME INDIA Learning Points
(By Dr S K Gupta, MD. Consultant physician, Max Hosp., New Delhi)
Finally government of India responded allowing increased dose interval of 4-8 wks between two doses of Covishield 👍. It is raised serious concerns among those who received doses as per previous schedule.
Q: What about so many of Doctors who took both doses four week apart🙄😭 Was it is insane?
A: The new recommendation is not 8 weeks’, it is 4 to 8 weeks.Previously it was not 4 weeks. It was 4 to 6 weeks Nothing to regret or worry about.
Q: If our antibody levels come low do we go through the same repeat process of two more doses of vaccines with a wider interval ?
A: I don’t think its necessary. Since two doses of vaccine irrespective of its interval taken was proven to prevent severe disease and death.
- Those who are still uneasy Phase 3 trial data which used two doses 4 weeks apart and declared on 22 March 21 could be a big breather
- Main findings of the US trial of Astra Zeneca Vaccine phase 3 trial report
- 79% vaccine efficacy at preventing symptomatic COVID-19
- 100% efficacy against severe or critical disease and hospitalisation
- Comparable efficacy result across ethnicity and age, with 80% efficacy in participants aged 65 years and over
- Favourable reactogenicity and overall safety profile
- AstraZeneca-led US Phase III trial included two doses administered at a four week interval. Previous trials have shown that an extended interval of up to 12 weeks demonstrated greater efficacy, which was also supported by immunogenicity data.
- Amongst participants Approximately 20% of participants were 65 years and over, and approximately 60% had co-morbidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity or cardiac disease.
- DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine.
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