Novavax Inc. expects regulators successful India, the Philippines, and elsewhere to marque a determination connected its COVID-19 vaccine wrong “weeks,” its main enforcement told Reuters, aft the changeable connected Monday received its archetypal exigency usage authorization (EUA) from Indonesia.
Novavax shares were up astir 13 percent aft the institution besides said it had filed an exertion for exigency usage of the vaccine to Canada and the European Medicines Agency.
For Indonesia, the changeable volition beryllium manufactured by the world’s largest vaccine manufacturer, Serum Institute successful India (SII), and sold nether the Indian company’s marque name, Covovax. Novavax said archetypal shipments into Indonesia are expected to statesman imminently.
The World Health Organization (WHO) is besides reviewing Novavax’s regulatory filing and the U.S. drugmaker expects that reappraisal to beryllium resolved successful the coming weeks, Chief Executive Stanley Erck told Reuters successful a telephone interrogation connected Monday.
A greenish airy from the WHO would acceptable the signifier for Novavax to statesman shipping doses to the COVAX programme that supplies shots to low-income countries. Novavax and SII person unneurotic committed to supply much than 1.1 cardinal doses to COVAX, which is co-led by the WHO.
“I deliberation we’ll get immoderate doses to COVAX this year,” Erck said. “But I deliberation [Novavax is] going to truly commencement being capable to vessel ample quantity to COVAX successful the archetypal quarter” of 2022.
Erck said Novavax has resolved each of its manufacturing challenges and does not expect regulators to person immoderate further concerns astir its accumulation processes.
He said Novavax is “in dialog with the U.S. FDA and … we expect a afloat submission wrong the adjacent respective weeks.”
Novavax had delayed filing for U.S. approval, and Politico reported past period that the institution faced accumulation and prime problems.
SII is authorized to marque the Novavax vaccine and the U.S. institution said it volition use for regulatory authorization for different facilities, specified arsenic its works successful the Czech Republic, successful the coming weeks.
Indonesia is slated to person 20 cardinal doses of the protein-based vaccine this year, according to the government.
Penny Lukito, main of the National Agency for Drug and Food Control of Indonesia, did not instantly respond to a Reuters petition for comment.
Novavax has truthful acold applied for EUA successful assorted countries, including the UK, Australia, India, and the Philippines.
“It volition beryllium weeks, not months, for them to review” Novavax’s regulatory submissions and perchance wide the changeable for use, Erck said.
The company, on with Japanese spouse Takeda Pharmaceutical Co., said connected Friday it was preparing to question regulatory support for a rollout successful Japan aboriginal adjacent year.
The Novavax changeable was shown to beryllium much than 90 percent effective, including against a assortment of concerning variants of the coronavirus successful a large, late-stage U.S.-based trial.
By Carl O’Donnell and Dania Nadeem
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