The CO­V­AX Fa­cil­i­ty is still stand­ing be­hind the As­traZeneca (AZ) vac­cine even in the face of a mul­ti-coun­try sus­pen­sion over con­cern of blood clots. To date, some 18 coun­tries have sus­pend­ed the use of the As­traZeneca vac­cine over con­cerns of blood clots.

T&T is part of the CO­V­AX Fa­cil­i­ty and re­ceived 33,600 AZ vac­cines at the end of March. The coun­try al­so re­ceived 40,000 dos­es from the Serum In­sti­tute of In­dia, man­u­fac­tured un­der the As­traZeneca la­bel for lo­cal use.

Guardian Me­dia reached out to GAVI, which is the vac­cine al­liance that dis­trib­utes vac­cines through the CO­V­AX Fa­cil­i­ty. Guardian Me­dia al­so reached out to the of­fice of the Chief Ex­ec­u­tive Of­fi­cer at the Serum In­sti­tute of In­dia. His of­fice di­rect­ed all me­dia ques­tions to an In­di­an-based Pub­lic Re­la­tions com­pa­ny. They have not yet re­spond­ed to ques­tions.

On Thurs­day, though, a GAVI spokesman said that it has been fol­low­ing the glob­al news but still be­lieves that the AZ vac­cine is "safe".

"En­sur­ing safe and ef­fec­tive vac­cines are pro­vid­ed to the most vul­ner­a­ble around the world is the top pri­or­i­ty for CO­V­AX. Gavi along with its CO­V­AX part­ners, in­clud­ing WHO (World Health Or­gan­i­sa­tion), is close­ly fol­low­ing the news," the spokesman said.

"De­ci­sions on the CO­V­AX port­fo­lio that re­late to safe­ty as well as rec­om­men­da­tions and guid­ance for use of vac­cine prod­ucts are based on WHO guid­ance."

The spokesman added, "WHO guid­ance on the use of the AZ vac­cine re­mains un­changed. As re­it­er­at­ed in state­ments by the Eu­ro­pean Med­i­cines Agency as well as WHO’s Glob­al Ad­vi­so­ry Com­mit­tee on Vac­cine Safe­ty (GVACS), the As­traZeneca vac­cine re­mains an im­por­tant pub­lic health tool against the COVID-19 pan­dem­ic and is ef­fec­tive at pre­vent­ing se­vere cas­es, hos­pi­tal­i­sa­tion and death."

The spokesman ac­cept­ed that the "speed with which vac­cines have been de­vel­oped in this pan­dem­ic has been un­prece­dent­ed" and ac­knowl­edged that the broad glob­al roll­out means that "oth­er very rare side ef­fects may be dis­cov­ered."

"That means this kind of care­ful mon­i­tor­ing is a crit­i­cal com­po­nent of emer­gency de­vel­op­ment and roll­out, al­low­ing the health care provider com­mu­ni­ty to ac­count for these very rare side ef­fects in the ad­min­is­tra­tion of the vac­cine, sim­i­lar to the ef­forts that would be–and are–un­der­tak­en with any oth­er ther­a­peu­tic or vac­cine," the spokesman said.

GAVI said that this al­so re-em­pha­sis­es the crit­i­cal need to have a range of safe and ef­fec­tive vac­cines avail­able glob­al­ly.

"Both the emer­gence of po­ten­tial­ly sig­nif­i­cant safe­ty sig­nals and new vari­ants un­der­scores the im­por­tance of con­tin­ued in­vest­ment in R&D and main­tain­ing a di­verse port­fo­lio of can­di­dates and ap­proach­es to vac­cine de­vel­op­ment–mean­ing vac­cines are avail­able that are ap­pro­pri­ate for use in a wide range of con­texts and set­tings," the group said.

PA­HO di­rec­tor de­fends vac­cine safe­ty for car­diac pa­tients

Lo­cal­ly one car­diac pa­tient passed away eight days af­ter re­ceiv­ing the first AZ shot and while the fam­i­ly is blam­ing the vac­cine for the blood clots that he de­vel­oped that left him paral­ysed be­fore his death, med­ical pro­fes­sion­als have said that the vac­cine was not to blame.

Sim­i­lar ques­tions are be­ing raised af­ter the sud­den pass­ing of En­er­gy Min­is­ter Franklin Khan who re­ceived his COVID-19 vac­ci­na­tion at the Diego Mar­tin Health Fa­cil­i­ty on Tues­day.

Khan, ac­cord­ing to re­ports, seemed in good health in the days fol­low­ing the in­oc­u­la­tion and his pass­ing was de­scribed as sud­den.

Khan al­so had a heart-re­lat­ed op­er­a­tion back in 2017 and un­der­went a "mi­nor" pro­ce­dure last year.

Di­rec­tor of the Pan Amer­i­can Health Or­gan­i­sa­tion (PA­HO) Dr Er­i­ca Wheel­er al­so de­fend­ed vac­cine safe­ty and its use for car­diac pa­tients.

In a text ex­change with Guardian Me­dia on Fri­day and yes­ter­day, Dr Wheel­er said that there was no ad­vi­so­ry for pa­tients with heart is­sue against tak­ing the vac­cine.

"Be­cause per­sons with un­der­ly­ing health con­di­tions are more like­ly to be­come se­vere­ly ill or die if they get COVID-19," she said yes­ter­day.

"How­ev­er, the ad­vice is al­ways if in doubt, per­sons must con­sult their doc­tor. Their doc­tors know their med­ical his­to­ry best."

Asked if the vac­cine was safe, Wheel­er said the vac­cine has been test­ed on thou­sands of peo­ple be­fore it was rolled out to the pub­lic.

"Yes, the AZ vac­cine is safe. It has been re­viewed by WHO and has been re­viewed for qual­i­ty, safe­ty and ef­fi­ca­cy," she said.

"The blood co­ag­u­la­tion events are to date seen as rare. The eval­u­a­tion of a vac­cine goes through dif­fer­ent phas­es (pre­clin­i­cal and clin­i­cal) un­til it re­ceives reg­u­la­to­ry ap­proval. The process is to en­sure a safe and ef­fec­tive vac­cine.

"There are 3 phas­es of tri­als two to three. By the time the vac­cine can­di­date reach­es phase 3 of a clin­i­cal tri­al, it is test­ed on sev­er­al thou­sands of peo­ple and this in­for­ma­tion is pro­vid­ed to WHO," she said.

"This is the last phase be­fore re­ceiv­ing reg­u­la­to­ry ap­proval by WHO."

Dr Wheel­er said that the WHO's Glob­al Ad­vi­so­ry Com­mit­tee on Vac­cine Safe­ty sys­tem­at­i­cal­ly re­views any vac­cine safe­ty sig­nals and con­cerns re­lat­ed to COVID-19 and ad­vis­es WHO on any new safe­ty sig­nals or con­cerns re­lat­ed to the vac­cines.

"This Com­mit­tee is care­ful­ly as­sess­ing the cur­rent re­ports re­lat­ed to the AZ vac­cine. As soon as there is a full un­der­stand­ing of these events, the find­ings and any un­like­ly changes to cur­rent rec­om­men­da­tions will be im­me­di­ate­ly com­mu­ni­cat­ed to the pub­lic," she said.

Wheel­er said that as of now "there is no ev­i­dence that the in­ci­dents are caused by the vac­cine and there­fore it is im­por­tant that vac­ci­na­tion cam­paigns con­tin­ue so that we can save lives and stop the se­vere dis­ease from the virus."

She said that as of March 12 over 300 mil­lion dos­es of COVID 19 vac­cines have been ad­min­is­tered since the start of the pan­dem­ic and no cas­es of death have been found to be caused by vac­cines.

Ac­cord­ing to Dr Wheel­er, be­fore the pause, the AZ vac­cine was giv­en to more than 19 mil­lion peo­ple in the UK with no ev­i­dence of re­lat­ed se­ri­ous ad­verse events.

"AZ man­u­fac­tur­ers al­so said there were no is­sues with qual­i­ty with any batch used across Eu­rope. Dur­ing the pro­duc­tion of the vac­cine, more than 60 qual­i­ty tests were con­duct­ed by the man­u­fac­tur­er, its part­ners and more than 20 in­de­pen­dent test­ing lab­o­ra­to­ries.

"All tests need to meet strin­gent cri­te­ria for qual­i­ty con­trol and these da­ta are sub­mit­ted to reg­u­la­tors for in­de­pen­dent re­view be­fore any batch is re­leased," she said.

Wheel­er said that ev­i­dence from As­traZeneca has shown that a care­ful re­view of all avail­able safe­ty da­ta of more than 17 mil­lion peo­ple vac­ci­nat­ed in the Eu­ro­pean Union and the UK "has shown no ev­i­dence of an in­creas­es risk of pul­monary em­bolism, deep vein throm­bo­sis or throm­bo­cy­tope­nia, (blood clots) in any de­fined age group, gen­der, batch of vac­cines or in any par­tic­u­lar coun­try."

"Whether these rare events that are pre­sum­ably linked to AZ and J&J which are still to be de­ter­mined," she said.

"The mes­sage is that the ben­e­fits still out­weigh the risks be­cause ad­verse events are very rare, while the risk of se­ri­ous ill­ness and death from COVID-19 is still high."