FDA Advisors Vote 21-0, with One Abstention, to Authorize Novavax’s Covid-19 Vaccine to be the Fourth US Option

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A pan­el of FDA’s out­side ex­perts rec­om­mend­ed 21 to 0, with one mem­ber ab­stain­ing, that the agency give emer­gency use au­tho­riza­tion for No­vavax’s two-dose Covid-19 vac­cine for peo­ple aged 18 years and old­er.
The ad­vi­sors’ vote of con­fi­dence was de­liv­ered days af­ter the FDA’s sci­en­tists de­ter­mined the vac­cine to be ef­fec­tive but with the caveat of po­ten­tial rare heart in­flam­ma­tion. Last au­tumn, pre-Omi­cron, the vac­cine was found to have a 90.4% ef­fi­ca­cy in a tri­al com­pris­ing 17,272 peo­ple giv­en a vac­cine and 8,385 peo­ple giv­en a place­bo.
“The Ad­vi­so­ry Com­mit­tee’s pos­i­tive rec­om­men­da­tion ac­knowl­edges the strength of our da­ta and the im­por­tance of a pro­tein-based COVID-19 vac­cine de­vel­oped us­ing an in­no­v­a­tive ap­proach to tra­di­tion­al vac­cine tech­nol­o­gy,” CEO Stan­ley Er­ck said in a state­ment. “We have heard in to­day’s VRB­PAC meet­ing the sig­nif­i­cant sup­port for our vac­cine from physi­cians, health­care or­ga­ni­za­tions, and con­sumers who are ea­ger­ly an­tic­i­pat­ing a pro­tein-based vac­cine op­tion. We look for­ward to the FDA de­ci­sion.”

Initial Results from Novavax’ COVID-19-Influenza Vaccine Trial are First to Show Feasibility of Combination Vaccine

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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax’ COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic.

In Conversation: Shannon Biermann, Senior Quality Control Manager – Microbiology at NextCure

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BioBuzz recently spoke with Shannon Biermann, who is a Senior Quality Control Manager of Microbiology at Beltsville, MD-based NextCure, to learn more about how she’s navigated her career in Microbiology QC thus far and how NextCure’s unique company culture helped her to take ownership and propel her career to the next level.

Novavax Announces Participation in Two Booster Studies Using its COVID-19 Vaccine

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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine, is included in two trials now underway to evaluate its vaccine’s safety, immunogenicity, and reactogenicity as a booster amidst the ongoing COVID-19 pandemic. Both studies have initiated participant enrollment and will help to extend knowledge of how a range of vaccines, including Novavax’ COVID-19 vaccine, can be used as boosters following primary immunization.

Novavax and Serum Institute of India Announce First Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents ≥12 to <18 in India

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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax’ protein-based COVID-19 vaccine for adolescents aged ≥12 to <18 years in India. The vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII under the brand name Covovax™ and is the first protein-based vaccine authorized for use in this age group in India.

Novavax Announces Launch of Global Vaccine Education Programs

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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the launch of its global unbranded ‘We Do Vaccines’ and ‘Know Our Vax’ programs, educational efforts aimed to help protect the health of people everywhere in the fight against COVID-19 and other deadly infectious diseases, such as influenza.

Novavax Reports Fourth Quarter and Full Year 2021 Financial Results and Operational Highlights

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Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2021.

Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine

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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.

Novavax and Serum Institute of India File for Emergency Use Authorization of Novavax’ COVID-19 Vaccine in South Africa

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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, today announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. If authorized, the vaccine (known as NVX-CoV2373) will be manufactured by and commercialized by SII in South Africa under the brand name Covovax™.

Maryland Real Estate Roundup 2021

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This year, Maryland continued to prove why it’s becoming one of the strongest biohealth clusters in the country. The state’s commitment to businesses in the life science, pharmaceutical, and biotech industries has continued as both the private and public sectors work to meet the demand for more space. Here are a few of the biggest real estate projects in Maryland in 2021. Some of these projects are still under construction, while others were unveiled this year.