The latest on COVID-19 vaccines/drugs and manufacturing from Moderna and Novavax. Highlights below.

Updates on COVID-19 Vaccines and Therapeutics
* UK Authorizes Moderna’s COVID-19 Vaccine Omicron Booster
* Novavax Files Emergency Use Authorization Request to FDA for COVID-19 Vaccine Booster

---

UK Authorizes Moderna’s COVID-19 Vaccine Omicron Booster
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorization to Moderna’s Omicron-containing bivalent COVID-19 booster vaccine as in individuals 18 years of age and older.

Moderna’s bivalent vaccine, mRNA-1273.214, contains the company’s primary COVID-19 vaccine, Spikevax, and a vaccine candidate targeting an Omicron variant of concern (BA.1).

Moderna reported that a booster dose of mRNA-1273.214 increased neutralizing geometric mean titers against Omicron approximately eight-fold above baseline levels. Moderna also reported that mRNA-1273.214 elicited neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to its currently authorized booster for the company’s primary vaccine.

Moderna has completed regulatory submissions for mRNA-1273.214 in Australia, Canada, and the European Union and expects further authorization decisions in the coming weeks (as reported on August 15, 2022).

Source: Moderna

---

Updates on COVID-19 Vaccines and Therapeutics

Novavax Files Emergency Use Authorization Request to FDA for COVID-19 Vaccine Booster
Novavax, a Gaithersburg, Maryland-based vaccine company, has submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of its COVID-19 vaccine booster in adults aged 18 and older as both a heterologous and homologous booster. The company had received EUA in the US of its primary COVID-19 vaccine, Nuvaxovid, as a two-dose series in individuals 18 years of age and older, in July (July 2022).

The company also provided regulatory updates for the vaccine and its booster in other countries.

In New Zealand, Medsafe, New Zealand’s pharmaceutical regulatory agency, granted expanded provisional approval for Nuvaxovid as a heterologous and homologous booster dose in adults aged 18 and older. Individuals may now choose Nuvaxovid as their first and/or second COVID-19 booster dose(s) after completion of their primary series using any of the authorized COVID-19 vaccines. New Zealand previously granted provisional approval for Nuvaxovid in adults aged 18 and older in February 2022.

In Taiwan, Novavax submitted a request for expanded EUA to Taiwan’s Food and Drug Administration for Nuvaxovid in adolescents aged 12 through 17. Taiwan previously authorized Nuvaxovid for individuals 18 and older in June 2022 and began administering doses of the vaccine in this population in July 2022.

In South Korea, Novavax’s partner, SK bioscience, received approval of Nuvaxovid from the Korean Ministry of Food and Drug Safety in adolescents aged 12 through 17. Nuvaxovid was authorized in South Korea for use in adults aged 18 and older in January 2022. In Korea, SK bioscience signed a licensing agreement with Novavax and is manufacturing drug substance and drug product of Nuvaxovid for domestic use in South Korea.

In Thailand, the Thailand Food and Drug Administration granted expanded EUA for Nuvaxovid in adolescents aged 12 through 17. The vaccine is manufactured and marketed by the Serum Institute of India under the brand name Covovax. Thailand granted EUA for the vaccine in April 2022 for use in adults aged 18 and older.

Source: Novavax (US), Novavax (New Zealand), Novavax (Taiwan), Novavax (South Korea), and Novavax (Thailand)