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GlaxoSmithKline and Sanofi said on Wednesday (December 15) they expect data from late-stage clinical trials of its booster dose of their Covid-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot. The news came as two companies said preliminary data from trials showed the single-dose booster provided strong immune responses. They added that they need more time to test the booster on more people who have not been infected by the virus before they can submit data to regulators. The Phase III trial for the recombinant adjuvanted Covid-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said. "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022." No safety concerns were identified. This is the latest delay for the vaccine's development, putting the companies further behind rivals in the race for Covid-19 shots.

New GSK raised its 2022 forecast for the second time this year, after third-quarter earnings and sales topped estimates, continuing its strong start as a standalone prescription medicine and vaccine business since carving out its consumer health division Haleon. After years of underperformance relative to its peers and missing out on the lucrative market for the first set of COVID-19 vaccines, GSK has delivered a string of strong results. The latest is led by a record quarter for its blockbuster shingles vaccine Shingrix and higher-than-expected revenue from its COVID therapy, Xevudy. Having survived a revolt by activist investors Elliott and Bluebell last year, GSK's prospects have been boosted by clinical trial success, though concerns remain around U.S. litigation over heartburn drug Zantac. Thousands of lawsuits have been filed in the United States against a raft of drugmakers over allegations the heartburn drug contains a probable carcinogen.

An alliance of companies has pledged to ensure equitable access to vaccines and treatments for pandemics, as the friction around intellectual property rights for Covid-19 interventions between the pharmaceutical industry and developing nations endures. At the heart of the plan is a commitment to set aside part of the production of vaccines and treatments upfront for vulnerable populations in low-income countries when the next pandemic arises, given how fragmented access to Covid tools has left many populations unprotected. In order to do better next time - and without knowing which companies will develop the first drugs and vaccines for the next pandemic - having the industry collectively make this commitment is potentially transformative, said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). The pledge, called the Berlin Declaration, was made on July 19 by members of the global pharmaceutical industry group that include many of the companies involved in developing Covid interventions, such as AstraZeneca, GSK, Moderna, Pfizer and Merck. The declaration is not legally binding. However, if a company that signed on reneges on its vow, it would face grave consequences in the court of public opinion, said Cueni.