COVID News: WHO, FDA, Novavax, Pfizer & BioNTech
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The latest on COVID-19 vaccines/drugs and manufacturing from the World Health Organization, The US Food and Drug Administration, the US Center for Disease Control and Protection, Novavax, Bharat Biotech, Pfizer, and BioNTech. Highlights below.  

Updates on COVID-19 Vaccines and Therapeutics 
* WHO Member States Agree To Develop Zero Pandemic Agreement  
* FDA Advisory Committee To Hold January Meeting on COVID-19 Vaccines   
* CDC Reports Increased Prevalence of COVID-19 Omicron Subvariants  
* Canada OKs Novavax’s COVID-19 Vaccine Booster 
* India OKs Bharat Biotech’s Intranasal COVID-19 Vaccine Booster
* Pfizer, BioNTech File for Emergency Use Authorization to FDA for Omicron-Adapted COVID-19 Vaccine Booster for Children Under Five 
* FDA Fast Tracks Pfizer/BioNTech Combo COVID-19 and Flu Vaccine 


Updates on COVID-19 Vaccines and Therapeutics  

WHO Member States Agree To Develop Zero Pandemic Agreement 
Member states of the World Health Organization (WHO) have begun the development of the first draft of a legally binding agreement focused on the response for future pandemics. This “zero draft” of the pandemic accord, rooted in the WHO Constitution, will be discussed by member states in February 2023. WHO made the announcement of the draft agreement in early December (December 2022).  

The body agreed that the Intergovernmental Negotiating Body (INB), comprised of WHO’s 194 member states, will develop the zero draft of the pandemic accord in order to start negotiations at the fourth INB meeting, scheduled to start on February 27, 2023. This draft will be based on the conceptual zero draft and the discussions during INB’s recent meeting. The INB Bureau is comprised of six delegates, one from each of the six WHO regions. 

Source: World Health Organization  


FDA Advisory Committee To Hold January Meeting on COVID-19 Vaccines 
The US Food and Drug Administration has announced that on Jan. 26, 2023, it will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the composition for primary doses of the currently available COVID-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward. Along with the independent experts of the advisory committee, representatives from the US Centers for Disease Control and Prevention and the National Institutes of Health will also participate in the meeting. 

At the upcoming January meeting, the agency is planning to examine the state of the pandemic, the evolution of variants and subvariants, and the available effectiveness, safety and immunogenicity data with the current monovalent and bivalent vaccines. The agency will also consider the potential composition of the current and next-generation COVID-19 vaccines for primary and booster immunization. There will also be presentations from manufacturers and the FDA summarizing the manufacturing considerations and timelines related to vaccine composition changes.  

Following the discussion and considering the advice provided by the VRBPAC at the meeting, the FDA will consider whether to recommend adjustments to the current authorizations and approvals and will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster COVID-19 vaccines. 

Source: The US Food and Drug Administration 


CDC Reports Increased Prevalence of COVID-19 Omicron Subvariants 
The US Center for Disease Control and Protection (CDC) reported on a new Omicron subvariant of COVID-19, XBB 1.5, has shown a surge in infections over the last few weeks as reported in December 2022. According to CDC data, XBB 1.5 is the second most circulating subvariant of Omicron, with 28% of new COVID-19 cases falling under the subvariant, as reported on January 7, 2023. The BQ.1.1 and BQ.1 Omicron subvariants respectively accounted for 34% and 21% of new COVID-19 infections, surpassing the BA.5 Omicron variant, which had been the most widely circulating variant over the summer; it now accounts for 3.7% of new COVID-19 cases.  

Source: Center for Disease Control and Protection 


Canada OKs Novavax’s COVID-19 Vaccine Booster 
Health Canada, the national pharmaceutical regulatory agency of Canada, has granted Novavax, a Gaithersburg, Maryland-based vaccine company, expanded authorization for its COVID-19 vaccine, Nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 as a homologous booster in adults aged 18 and older. 

Novavax’ vaccine has been authorized as a heterologous and homologous booster in the US, EU, UK, Japan, Australia, New Zealand, and Switzerland. Health Canada previously authorized Nuvaxovid as a primary series in adults aged 18 and older in February 2022. Novavax filed in Canada for the vaccine’s use as a primary series in adolescents aged 12 through 17 in June 2022. 

Source: Novavax 


India OKs Bharat Biotech’s Intranasal COVID-19 Vaccine Booster 
The Central Drugs Standard Control Organization, the national pharmaceutical regulatory agency of India, has granted Bharat Biotech, a Hyderabad, India-based bio/pharmaceutical company, approval for iNCOVACC, Bharat’s intranasal COVID-19 vaccine, under Restricted Use in Emergency Situation as a heterologous booster doses in individuals 18 and above.  

iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein. iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries. 

Source: Bharat Biotech 


Pfizer, BioNTech File for Emergency Use Authorization to FDA for Omicron-Adapted COVID-19 Vaccine Booster for Children Under Five 
Pfizer and BioNTech, a Mainz, Germany-based bio/pharmaceutical company submitted in early December (December 2022) an application to the US Food and Drug Administration for emergency use authorization of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.  

If authorized, children in this age group would receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine followed by a third 3-µg dose of the Omicron BA.4/BA.5-adapted bivalent vaccine. An application to extend Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine marketing authorization in the EU to include children ages 6 months through 4 years is under discussion with the European Medicines Agency. 

The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized as a booster dose for individuals aged 5 years and older in the US and EU. 

Source: BioNTech 


FDA Fast Tracks Pfizer/BioNTech Combo COVID-19 and Flu Vaccine   
The US Food and Drug Administration (FDA) granted Pfizer and BioNTech in early December (December 2022) fast-track designation for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection.  

Pfizer and BioNTech previously announced the start of a Phase I trial to examine the safety, tolerability, and immunogenicity of their combined influenza and COVID-19 candidate vaccine among healthy adults. 

The vaccine candidate is based on BioNTech’s mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron variants BA.4/BA.5, as well as mRNA strands encoding the hemagglutinin of four different influenza strains. 

Source: BioNTech