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STORY: WHO / COVID-19 VACCINE EXPERTS
TRT: 4:57
SOURCE: WHO
RESTRICTIONS: NONE
LANGUAGE: ENGLISH / NATS
DATELINE: 10 FEBRUARY 2021, GENEVA, SWITZERLAND
FILE - GENEVA, SWITZERLAND
1. Wide shot, WHO emblem outside headquarters
10 FEBRUARY 2021, GENEVA, SWITZERLAND
2. Wide shot, official at press conference
3. SOUNDBITE (English) Dr Soumya Swaminathan, Chief Scientist, World Health Organization:
“These guidelines that are being released today are very, very important because the Oxford AstraZeneca vaccine is one of the main vaccines at this point in the COVAX Facility. It's going to be procured in hundreds of millions of doses and distributed around the world. And so, many countries will be receiving their first tranches of the vaccine from the COVAX Facility later in February. So, this is an important milestone and we hope that this will be followed very soon by the recommendation on the Emergency Use Listing of this product.”
4. Wide shot, official at press conference
5. SOUNDBITE (English) Dr Alejandro Cravioto, Chair, Strategic Advisory Group of Experts (SAGE) on Immunization:
“In the case of the AstraZeneca vaccine, we had a long review of the evidence, talked to the experts and the people who are directly involved with the trials, and we have come up with the following recommendations. Based on the current evidence, SAGE recommends that this vaccine should be administered in two doses of half a millilitre each with an interval of between 4 and 12 weeks between the first and the second dose. And given the evidence that we saw, we realized that extending the evidence between 8 and 12 weeks is the best time really to give a second dose to produce a much better immune response.”
6. Wide shot, official at press conference
7. SOUNDBITE (English) Dr Alejandro Cravioto, Chair, Strategic Advisory Group of Experts (SAGE) on Immunization:
“In the case of the data that coming from clinical trials, we have seen that there was a small participation of people over 65 years of age. However, the results of the efficacy estimate for persons up to 65 and older had a wide confidence interval. And therefore, we feel that the response of this group thus cannot be any different to groups that are of a younger age. So we therefore, since we have identified people over 65 as one of our priority groups in the prioritization roadmap, we have based a totality of looking at the safety and the immunogenicity data and therefore would recommend for the vaccine to be used in people 18 years and above without an upper age limit. That means people over 65 years of age should be given the vaccination.”
8. Wide shot, official at press conference
9. SOUNDBITE (English) Dr Kate O'Brien, Director, Department of Immunizations, Vaccines and Biologicals, World Health Organization (WHO):
"The important thing to remember is that the AstraZeneca vaccine is an efficacious vaccine. It has demonstrated efficacy and safety, and it is an important vaccine for the world given the short supply that we have in vaccines."
10. Wide shot, official at press conference
11. Dr Alejandro Cravioto, Chair, Strategic Advisory Group of Experts (SAGE) on Immunization (soundbite begins on wideshot of room)
“I think one of the considerations that SAGE is making is the need to stop severe disease and mainly people dying and withholding a recommendation for a number of weeks waiting for more information when we have enough to make a recommendation I think would not be appropriate. We have thousands of people dying from infection in many countries of the world daily. And I think anything we can do to use a product that might reduce that is totally justified, even if the information is not as complete as we would like.”
12. Wide shot, official at press conference
13. SOUNDBITE (English) Dr Kate O'Brien, Director, Department of Immunizations, Vaccines and Biologicals, World Health Organization (WHO):
“Manufacturers have responsibilities here as well, and they can help to make this global access easier. And the ways that they can do that: number one, is prioritizing the submission of data to WHO for Emergency Use Listing (EUL). We are unable to move on EUL unless we actually have the data to evaluate. We do expect that manufacturers will make that a priority as some of their - after the submission for the first authorization that allows the marketing of the product, we would really ask that manufacturers make WHO EUL their next stop. And that, that consultation be happening while the data are in development so that there is a readiness and a preparation to know what will be required and to be able to submit it.”
14. Wide shot, official at press conference
WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommended the use of the Oxford AstraZeneca COVID-19 vaccine “based on the current evidence.”
SAGE is The Strategic Advisory Group of Experts on Immunization (SAGE) is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions.
Speaking at a press conference in Geneva today (10 Feb), WHO Chief Scientist Dr Soumya Swaminathan said the guidelines that are being released today are very, very important because the Oxford AstraZeneca vaccine is one of the main vaccines at this point in the COVAX Facility. She said, “It's going to be procured in hundreds of millions of doses and distributed around the world. And so, many countries will be receiving their first tranches of the vaccine from the COVAX Facility later in February. So, this is an important milestone and we hope that this will be followed very soon by the recommendation on the Emergency Use Listing of this product.”
SAGE Chair Dr Alejandro Cravioto said the group made its recommendation following a long review of the evidence and talks with the experts and the people who are directly involved with the trials. He said the recommendation would be to administer the Oxford AstraZeneca vaccine in two doses of half a millilitre each with an interval of between 4 and 12 weeks between the first and the second dose. He added, “Given the evidence that we saw, we realized that extending the evidence between 8 and 12 weeks is the best time really to give a second dose to produce a much better immune response.”
Cravioto said, “In the case of the data that coming from clinical trials, we have seen that there was a small participation of people over 65 years of age. However, the results of the efficacy estimate for persons up to 65 and older had a wide confidence interval. And therefore, we feel that the response of this group thus cannot be any different to groups that are of a younger age. So we therefore, since we have identified people over 65 as one of our priority groups in the prioritization roadmap, we have based a totality of looking at the safety and the immunogenicity data and therefore would recommend for the vaccine to be used in people 18 years and above without an upper age limit. That means people over 65 years of age should be given the vaccination.”
The SAGE Chair noted that one of the considerations taken by the team was “the need to stop severe disease and mainly people dying.” He stressed that withholding a recommendation for a number of weeks waiting for more information “when we have enough to make a recommendation, I think would not be appropriate. We have thousands of people dying from infection in many countries of the world daily. And I think anything we can do to use a product that might reduce that is totally justified, even if the information is not as complete as we would like.”
Dr Kate O'Brien, Director of WHO’s Department of Immunizations, Vaccines and Biologicals said the important thing to remember is that the AstraZeneca vaccine is an “efficacious vaccine; it has demonstrated efficacy and safety, and it is an important vaccine for the world given the short supply that we have in vaccines."
O’Brien said manufacturers can help to make global access to a vaccine easier. By “prioritizing the submission of data to WHO for Emergency Use Listing (EUL).” She said, “We are unable to move on EUL unless we actually have the data to evaluate.” She noted that after the submission for the first authorization that allows the marketing of the product, WHO would “really ask that manufacturers make WHO EUL their next stop.” She said consultation can occur while the data are in development so that there “is a readiness and a preparation to know what will be required and to be able to submit it.”
