World Health Organization (WHO)

Subject:

WHO Strategic Advisory Group of Experts on Immunization (SAGE) presenting its interim recommendations on the use of Johnson & Johnson COVID-19 vaccine

Speakers:

• Dr Alejandro CRAVIOTO, Chair, Strategic Advisory Group of Experts (SAGE) on Immunization

• Dr Annelies WILDER-SMITH, Technical Advisor to the SAGE Secretariat, WHO
• Dr Kate O’BRIEN, Director, Department of Immunization, Vaccines and Biologicals, WHO

Health experts give green light to Janssen COVID jab, allay clotting concerns

The Janssen COVID-19 vaccine was publicly approved for international use on Wednesday by UN health agency expert advisory board, SAGE, which allayed concerns over clotting events being associated by some countries, without definitive evidence, with coronavirus jabs.

“After reviewing the evidence, we have a vaccine that shows to be safe and it shows to be, have the necessary efficacy to be recommended by us for use in people above the age of 18 without an upper age limit,” said Dr Alejandro Cravioto, Chair of the Strategic Advisory Group of Experts on Immunization (SAGE).

“This is a one single-dose vaccine given intramuscularly, which is a regular advantage of having the capacity to vaccinate more people but not different in reality in its capacity to protect against severe disease or death.”

In a virtual press conference from Geneva, the SAGE experts hailed the one-dose Janssen shot – produced by a Johnson & Johnson subsidiary - as a safe and lifesaving addition to the three other vaccines it has already approved for use: Pfizer, Moderna and AstraZeneca.

“The world is in a place where there is insufficient supply to meet the requirements of people who need to be vaccinated. And clearly, any of these vaccines are lifesaving products,” said Dr Kate O’Brien, Director, Department of Immunization, Vaccines and Biologicals, World Health Organization (WHO).

Dr O’Brien insisted that the vaccines “need to be used as quickly as we can get them deployed. People can have confidence in their safety and efficacy and in the quality of the manufacture of the products.”

The expert panel also noted that clotting episodes - also known as hypercoagulable events - were a symptom of COVID-19, amid the suspension of the AstraZeneca/Oxford vaccine by several European countries, pending scientific review.

“Obviously, thrombo-embolic events are indeed a phenomenon of the disease itself, of COVID-19 itself, and therefore we do need to look out for thrombo-embolic events in general and we are,” said Dr Annelies Wilder-Smith, Technical Advisor to the SAGE Secretariat.

Dr Wilder-Smith assessed the findings of the Janssen coronavirus vaccine trial, noting that the relatively similar reported side-effects among the placebo and vaccinated groups were “about the same”:

“The trial had about 44,000 subjects, so half of them, about 22,000, did not receive the vaccine and therefore are called the placebo arm; and indeed in that group - and that’s good to know as a comparison or as a background - there were 10 cases of thrombo-embolic events so clots be it either deep vein thrombosis or pulmonary embolism or another big clot So this is your background, so they were 10 in 22,000 in the placebo arm. In the vaccinated arm, in the arm that - in the group that received the Janssen vaccine - there were 14 events also out of 22,000. So, this is about the same, there’s a slight imbalance but it’s still not statistically significant.”

No reason for clots from vaccines

As for the vaccine, Dr Wilder-Smith added that there was “no reason to think and no biological causability as far we understand now, that the vaccine could cause thrombo-embolic events itself. However, we have to be open for new events, and we have to take it seriously.”

The SAGE official also explained that those recruited for vaccine testing were intentionally chosen because they were people who were “at high risk” of developing blood clots.

“COVID really pre-disposes patients to a hypercoagulable state where indeed many of the deaths that we see in the severe cases are due to thrombo-embolic events”, Dr Wilder-Smith said, ahead of an expected announcement by the European Medical Agency (EMA) on the issue on Thursday.

After giving the green light to the Janssen jabn, SAGE chair Dr Cravioto also insisted on the need to tackle COVID-19 variants more effectively.

There needed to be “a coordinated approach regarding the vigilance of the circulation of the variants and that requires countries to share information to increase the search for these variants through systems that allow them to sequence the virus and see where they are and especially how high-risk groups are affected  by this issues,” he said.

To date, there is no COVID-19 vaccine for children, the SAGE chair continued, noting also that no firm advice could yet be issued for pregnant women wishing to have the jab - although the vaccine “platform” used to deliver the Janssen jab in common with the Ebola vaccine had shown “no safety issues” among the 1,600 women who had received it.

“In the case of children below 18 years of age, we still do not have a vaccine that is useful for them, the Pfizer one has been recommended after 16 years  but that’s all,” said Dr Cravioto. “But we know that there are a number of vaccines being already tested in children up to 12 years or even younger and we hope to have that information soon to be able to protect that group also.”

The development comes amid a rise in new cases of coronavirus infection worldwide, increasing by 10 per cent in the past week, to more than three million new reported cases.

WHO reported on Wednesday that after peaking in early January 2021 - when there were just under five million cases a week - new cases then declined to around 2.5 million in the week commencing 15 February 2021.

But the past three weeks have seen cases increasing again.

This week, the Americas and Europe continue to account for more than 80 per cent of new cases and new deaths, with rises in new cases in all regions - apart from Africa, where they remained the same as last week.

As of 17 March 2021, there have been 120,164,106 confirmed cases of COVID-19, including 2,660,422 deaths, reported to WHO.

More than 363,000,000 vaccine doses have been administered globally.

1. Exterior wide shot, Palais des Nations flag alley, nations’ flags flying.
2. SOUNDBITE (English) — Dr Alejandro CRAVIOTO, Chair, Strategic Advisory Group of Experts (SAGE) on Immunization: “After reviewing the evidence, we have a vaccine that shows to be safe and it shows to be, have the necessary efficacy to be recommended by us for use in people above the age of 18 without an upper age limit. This is a one single-dose vaccine given intramuscularly, which is a regular advantage of having the capacity to vaccinate more people but not different in reality in its capacity to protect against severe disease or death.”
3. Exterior wide shot, UN Flag flying, Palais des Nations.
4. SOUNDBITE (English) — Dr Kate O’BRIEN, Director, Department of Immunization, Vaccines and Biologicals, WHO (World Health Organization): “The world is in a place where there is insufficient supply to meet the requirements of people who need to be vaccinated. And clearly, any of these vaccines are lifesaving products.”
5. Exterior wide shot, Palais des Nations flag alley, nations’ flags flying.
6. SOUNDBITE (English) — Dr Annelies WILDER-SMITH, Technical Advisor to the SAGE Secretariat, WHO(World Health Organization): “Obviously, thrombo-embolic events are indeed a phenomenon of the disease itself, of COVID-19 itself, and therefore we do need to look out for thrombo-embolic events in general and we are.”
7. Exterior wide shot, United Nations building.
8. SOUNDBITE (English) — Dr Annelies WILDER-SMITH, Technical Advisor to the SAGE Secretariat, WHO(World Health Organization): “The trial had about 44,000 subjects, so half of them, about 22,000, did not receive the vaccine and therefore are called the placebo arm; and indeed in that group - and that’s good to know as a comparison or as a background - there were 10 cases of thrombo-embolic events so clots be it either deep vein thrombosis or pulmonary embolism or another big clot So this is your background, so they were 10 in 22,000 in the placebo arm. In the vaccinated arm, in the arm that - in the group that received the Janssen vaccine - there were 14 events also out of 22,000. So, this is about the same, there’s a slight imbalance but it’s still not statistically significant.”
9. Exterior wide shot, Palais des Nations flag alley, nations’ flags flying, a cloudy day.
10. SOUNDBITE (English) — Dr Alejandro CRAVIOTO, Chair, Strategic Advisory Group of Experts (SAGE) on Immunization: “We are continuing to insist that there needs to be a coordinated approach regarding the vigilance of the circulation of the variants and that requires countries to share information to increase the search for these variants through systems that allow them to sequence the virus and see where they are and especially how high-risk groups are affected  by this issues.”
11. Exterior wide shot, Palais des Nations flag alley, nations’ flags flying, a cloudy day.
12. SOUNDBITE (English) — Dr Alejandro CRAVIOTO, Chair, Strategic Advisory Group of Experts (SAGE) on Immunization: “In the case of children below 18 years of age, we still do not have a vaccine that is useful for them, the Pfizer one has been recommended after 16 years  but that’s all, but we know that there are a number of vaccines being already tested in children up to 12 years or even younger and we hope to have that information soon to be able to protect that group also.”
13. Exterior wide shot, Palais des Nations flag alley.