Dr. Henrietta Ugwu is the Nigerian Chief Regulatory and Quality Officer at the United States (US) vaccine company, Novavax, whose COVID-19 vaccine has just received approval of European Union for use.

The EU authorization of the Novavax’ Nuvaxovid vaccine makes the Gaithersburg company’s two-dose vaccine the fifth to get approval for use in European countries.

Prior to this feat, Ukwu led global regulatory strategy and execution as well as quality assurance function for the company’s development-stage vaccine candidates, including its recombinant protein-based COVID-19 candidate vaccine, NVX-CoV2373.

“Dr. Ukwu brings extensive regulatory affairs and quality expertise and leadership experience at precisely the right time for Novavax, as we advance toward data readouts and regulatory submissions in 2021,” Stanley Erck, President and Chief Executive Officer, Novavax had said during her appointment early this year.

“We welcome her medical perspective and intricate knowledge of the regulatory process at this extraordinary time for the company and the race against the global pandemic.”

Ukwu most recently served as Chief Regulatory Officer and Global Head of Quality and Regulatory at Otsuka Pharmaceuticals. While there, she globalized and led the regulatory and quality organizations with a focus on compliance excellence, inspection readiness, engagement with health authorities and regulatory agencies and successful outcomes. Prior to Otsuka, she held senior leadership roles at PPD as Senior Vice President and Head of Global Regulatory Affairs, where she had responsibilities for regulatory services across all PPD lines of business; Wyeth Pharmaceuticals, Inc. (Pfizer), where she was Vice President, Regulatory Affairs, with responsibility that spanned vaccines, biologics and pharmaceuticals across all regions; and at Merck & Co., Inc., as Head of Vaccine Regulatory Development, Vice President of Global Regulatory Affairs and Global Regulatory Policy.

The Scientist has led approval of many products, including for Varivax®, a chickenpox varicella vaccine, and Crixivan®, (indinavir), an HIV protease inhibitor that significantly impacted the treatment paradigm of HIV/AIDS.

Ukwu’s significant contributions to medicine, science and the pharmaceutical industry include developing and enriching the regulatory and quality profession, as well as serving as a mentor to others who have progressed into senior leadership positions. These contributions have been recognized with numerous prestigious awards.

Nuvaxovid is manufactured in partnership with the Serum Institute of India. Similarly, the World Health Organisation (WHO) last week issued an emergency-use listing to Nuvaxovid.

This authorization encourages countries without sophisticated review systems to use the vaccine without local testing. The WHO endorsement helps Novavax push the vaccine to countries without local capacity to independently review vaccines.

Ukwu said the vaccine has unique attributes that enhance its potency and acceptability.

“One of these is that Nuvaxovid, which is 90 per cent effective, can be easily stored. Only one other vaccine has this attribute.

“It can be preserved in a refrigerator storage,” Ukwu explained in a learning platform.

“This makes it possible to get this vaccine to so many parts of the world challenged with cold chain storage.”

Ukwu also said that being a protein-based vaccine should endear it to “vaccine hesitant.”

“Over time, protein-based vaccines proved to be safer and with no or mild side effects. As Chief Regulatory Officer, I am especially proud of the entire Novavax Team for this exceptional contribution to humanity,” Ukwu said.

The company hopes to submit an application for approval of the Omicron version to US regulators by month end.

Apart from India where the vaccines are manufactured, Nuvaxovid has also passed regulatory tests in Indonesia and Philippines. The company plans to roll out over two billion doses in the coming year.

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