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.
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.
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.
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.
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.
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.
LONDON – The EMA set out the reasons for why it is diverging from the FDA on booster doses of Pfizer Inc.’s/Biontech SE’s COVID-19 vaccine, despite having reviewed the same data.
LONDON – The EMA has changed its stance on booster doses of the Pfizer Inc./Biontech SE COVID-19 vaccine and said they “may now be considered” at least six months after the second dose for people ages 18 and over.
Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind.
LONDON – Self-amplifying RNA (saRNA) specialist Vaxequity Ltd. has sealed a commercialization deal with Astrazeneca plc after delivering safety data in a phase I/II trial of the technology in a COVID-19 vaccine.
