AstraZeneca’s lead researcher Mene Pangalos signaled that the company may be refraining from submitting its Covid-19 vaccine to the US FDA for approval, citing months of discussions with the regulator.
“We do not have to push it in places we do not need or want,” Pangalos said Financial Times on Thursday. “If we do not end up submitting it to a BLA [biologics license application]I do not think it will have an impact around the world. ”
While more than 2.5 billion non-profit Covid shots from the UK-based drug maker have been shipped worldwide, the road to marketing in the US, where Pfizer and Moderna have dominated, has been top notch, despite a contract of $ 1.2 billion to $ 300 million. doser.
So far, the United States has donated 60 million AstraZeneca vaccine doses made by a contractor at a troubled manufacturing facility in Baltimore.
Last March, the NIH also took the unusual step of releasing a statement in the middle of the night that raised new questions about data from AstraZeneca’s US-based Covid-19 vaccine trial. The DSMB, which is monitoring the trial, “expressed concern that AstraZeneca may have included outdated information from this trial, which may have provided an incomplete overview of the efficacy data,” according to the NIH.
But NIAID’s Tony Fauci later clarified that the vaccine’s “data is really pretty good, but when they put it in the press release, it was not entirely accurate.”
35 generic drug manufacturers worldwide are starting to manufacture Pfizer’s antiviral drug
The world’s best Covid-19 antiviral drug is seeing a much wider entry into 95 low- and middle-income countries, as 35 generic drug manufacturers want to expand production of Pfizer’s pill.
Thanks to sub-licenses via the UN-backed Medicines Patent Pool, with which Merck is also collaborating to expand the range of its antiviral molnupiravir, six companies will focus on producing the drug Paxlovid, nine companies will produce the drug and the rest will do both.
After the pandemic period, the contracts with the companies stipulate that sales to low-income countries remain royalty-free, while sales to lower middle-income countries and upper middle-income countries will be subject to a royalty of 5% for sales to the public sector and 10% royalty for sales to the private sector.
Felipe de Carvalho, MSF Access Campaign Coordinator in Brazil, said in a statement:
Agreements concluded between MPP and 35 producers to produce and supply nirmatrelvir / ritonavir [Paxlovid] is a welcome step, but the agreement covers only 53 percent of the world’s population and excludes millions of people in middle-income countries. Most Latin American countries, including Brazil, are excluded from this agreement, as are other middle-income countries, such as China, Malaysia and Thailand – this will have a cooling effect on the availability of more affordable generic versions of the manufactured drug under this license, if Pfizer is granted patents in these countries.
Ivermectin falls short of preventing Covid-19 admissions in new study
A new Brazilian trial of nearly 1,400 Covid-19 patients at risk for serious illness shows that those who received three days of the antiparasitic drug ivermectin did not perform better than those who received placebo, according to Wall Street Journal.
“This is the first large, prospective study that really should help bring ivermectin to rest and give no credibility to its use for Covid-19,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College. of Medicine, told the Journal.
NIH, which last updated its guidance on February 11, recommends neither for nor against the use of ivermectin for the treatment of Covid-19.