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BioWorld - Thursday, April 30, 2026
Home » Topics » Vaccine, BioWorld

Vaccine, BioWorld
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U.S. vaccine illustration

FDA authorizes boosters for Moderna, J&J vaccines; clears mix-and-match use

Oct. 20, 2021
By Jennifer Boggs
As largely expected, the FDA on Oct. 20 authorized the use of booster doses for COVID-19 vaccines from Moderna Inc. and Johnson & Johnson, in line with last week’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings. It also cleared the way for “mix-and-match” boosters, allowing eligible people to receive boosters from any of the FDA-approved vaccines, regardless of which vaccine they received originally.
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COVID-19 mRNA vaccine vials, syringe

Baidu algorithm-based mRNA vaccine neutralizing antibody titer levels exceed benchmark sequence by up to 20x

Oct. 19, 2021
By Doris Yu
Baidu Inc.’s preclinical studies showed the mRNA vaccine sequences for COVID-19 designed using its Lineardesign algorithm outperformed the benchmark sequences designed by traditional algorithms in terms of stability, protein expression and immunogenicity. The firm teamed up with Stemirna Therapeutics Co. Ltd., which specializes in the R&D of mRNA vaccines and drugs, to test seven mRNA COVID-19 vaccine sequences designed using Lineardesign.
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Valneva vaccine vials

Regulatory submissions ahead on solid phase III data for Valneva’s COVID-19 vaccine

Oct. 18, 2021
By Nuala Moran
LONDON – Valneva SA’s COVID-19 vaccine, VLA-2001, prompted a stronger immune response with fewer side effects than Astrazeneca plc’s product, according to headline data from the phase III trial. Shares in Valneva (NASDAQ:VALN) shot up by nearly 40% to close Oct. 18 at $39.21 when the data were announced, partly repairing the damage on Sept. 13 when the U.K. government cancelled a $1.65 billion contract with the French vaccines specialist for 100 million doses.
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Janssen COVID-19 vaccine vial

FDA adcom unanimously supports a booster for Janssen’s COVID-19 vaccine

Oct. 15, 2021
By Lee Landenberger
The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously agreed to recommend a booster dose of Janssen Biotech Inc.’s COVID-19 vaccine for those age 18 years and older at least two months following the first dose. In the end, the vote swung on numbers from Janssen showing a booster significantly improved efficacy among study participants. Janssen’s data leaped to 94% protection after a booster dose, up from 70% efficacy following the first dose. That higher efficacy rate nearly matches that of the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE.
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Moderna COVID-19 vaccine

Unanimous booster vote more a desire to avoid confusion

Oct. 14, 2021
By Mari Serebrov
Given the FDA’s Vaccines and Related Biological Products Advisory Committee’s unanimous vote last month to recommend use of a booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine in certain high-risk groups, it came as no surprise when the committee again voted unanimously Oct. 14 for a mirror use of Moderna Inc.’s proposed booster.
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Syringe with Johnson & Johnson logo

FDA briefing docs build stronger case for 2nd J&J vaccine dose

Oct. 13, 2021
By Mari Serebrov
Should Johnson & Johnson’s (J&J) COVID-19 vaccine be a two-dose series? While not directly asked, that question almost lurks between the lines of the FDA’s briefing document for the Oct. 15 meeting of its Vaccines and Related Biological Products Advisory Committee. The document referred to J&J’s proposed second dose as a “booster,” but the FDA isn’t asking the committee the questions it posed for the Moderna Inc. and Pfizer Inc.-Biontech SE boosters. Instead, it is inviting VRBPAC to advise on whether the second J&J dose should be administered two months or six months following the first shot.
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ECTRIMS opens: Biogen therapies did not reduce COVID-19 antibody responses in MS patients

Oct. 13, 2021
By Lee Landenberger
Biogen Inc. opened the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting with data showing those treated with its multiple sclerosis (MS) therapies had an effective antibody response to COVID-19 vaccination.
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FDA preps for rounds 2 and 3 of booster adcom

Oct. 12, 2021
By Mari Serebrov
Although the need for COVID-19 boosters remains a tense debate among policymakers and scientific experts worldwide, the U.S. FDA is basing its Oct. 14-15 Vaccines and Related Biologics Products Advisory Committee meeting on the premise that vaccine boosters are needed.
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Curevac vial

Curevac quits early COVID-19 vaccine program to work on next-gen candidate, scrubbing EC purchase agreement

Oct. 12, 2021
By Michael Fitzhugh
Curevac AG, once a forerunner in COVID-19 vaccine development but later surpassed, said it would terminate its first effort in the field, CVnCoV, withdrawing it from a rolling review at the EMA to focus instead on development of second-generation mRNA vaccine candidates with Glaxosmithkline plc.
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WHO recommends ‘long-awaited’ malaria vaccine backed by real-world data

Oct. 7, 2021
By Nuala Moran
LONDON – The World Health Organization (WHO) is recommending the widespread rollout of Glaxosmithkline plc’s Mosquirix (RTS,S), the first malaria vaccine, following real-world evidence it is safe and can be integrated into routine immunization programs and existing malaria control measures.
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