AstraZeneca's EUA remains despite halted South Africa rollout — FDA
MANILA, Philippines — Local regulators said Tuesday that the emergency use approval for AstraZeneca's coronavirus vaccine would remain despite developments in South Africa where the jabs' rollout was halted after its dismal showing against a new variant detected there.
Clinical trials in Johannesburg had concluded that the British-Swedish drugmaker's vaccine provided only "minimal" protection against mild to moderate COVID-19 caused by the said variant, pushing the South African government to halt the rollout.
But over a Laging Handa briefing, Food and Drug Administration chief Eric Domingo said no changes are expected yet, as the variant has not been detected so far in the country.
"Ang circulating virus dito sa atin ay kahawig na kahawig pa rin ng original virus na ginamit para i-develop 'yung AstraZeneca," he said. "So at this time, andiyan pa rin naman ang ating EUA. Walang pagbabago ito."
(The circulating virus here is sill looking the same as the original virus that was used to developed the AstraZeneca. So at this time, the EUA remains and there is no change.)
The World Health Organization has also sought to respond to concerns over the jabs, insisting that it remains a vital tool in the fight against the pandemic.
"It is vastly too early to be dismissing this vaccine," said Richard Hatchett, who heads the Coalition for Epidemic Preparedness Innovations (CEPI), which co-leads the Covax vaccine facility with the WHO and Gavi after the AstraZeneca shot ran into a number of setbacks, including questions about its efficacy for over-65s.
Authorities in the Philippines are expecting some 5.5 million doses of AstraZeneca to arrive this February, under the COVAX facility, a global initiative to ensure fair and equitable access to vaccines.
The millions are still separate from the 2.6 million doses that the private sector secured in November of 2020, which is seen to arrive by second quarter of this year.
Apart from AstraZeneca, the FDA has also cleared Pfizer for emergency use, and is included in the COVAX facility at 117,000 doses, per vaccine czar Carlito Galvez Jr.
Still, Domingo said they are preparing as well for vaccine developments should the variant first detected in South Africa reach the country's shores.
"Kaya nire-require natin sila na kailangan kumpletuhin ang development kasi mino-monitor nga po nila at kung kakailanganin, maaring i-revise o i-tweak ng onti 'yung vaccines para maging responsive siya sa newer variants," he said.
(That's why we are requiring them to complete their development because they too are still monitoring. And if needed, they may revise or teak some of the vaccines to make it responsive to newer variants.)
The Philippines confirmed its first case of the UK variant on January 13. The figure has grown since then, reaching 25 to date with one dead and 22 already recovered, per the health department.
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