Covid-19 roundup: Pfizer says Xeljanz reduced death and lung failure in hospitalized Covid-19 patients; US halts distribution of Eli Lilly’s mAb combo to Rhode Island due to variants
In addition to its ultra-effective mRNA vaccine, Pfizer believes it could have another weapon to fight the Covid-19 pandemic.
The company reported on Wednesday that its rheumatoid arthritis blockbuster Xeljanz significantly lowered the incidence of death or respiratory failure in hospitalized patients with Covid-19 pneumonia in Brazil.
“To effectively combat the COVID-19 pandemic, there remains a critical need for multiple therapeutic options to treat patients who have contracted the virus,” Tamas Koncz, CMO of Pfizer Inflammation & Immunology, said in a statement.
The trial — conducted in collaboration with the Academic Research Organization (ARO) from the Hospital Israelita Albert Einstein in Sao Paulo, Brazil — enrolled 289 hospitalized adults who were not on ventilation. Most of the patients (89.3%) also used glucocorticoids during hospitalization, predominantly dexamethasone.
Patients in the treatment arm received two 10 mg doses a day, for up to 14 days or until hospital discharge. At Day 28, death or respiratory failure occurred in 18.1% of Xeljanz patients, compared to 29% in the placebo group (p=0.04). Death from any cause through day 28 was 2.8% in the Xeljanz group and 5.5% in the placebo group.
As for safety, serious adverse events occurred in 20 patients (14.1%) in the Xeljanz group and 17 patients (12%) in the placebo group.
“We look forward to our continued collaboration as we analyze the full dataset from this study and assess next steps,” Koncz said.
US halts distribution of Eli Lilly’s mAb combo to Rhode Island due to variants
The US government is adding Rhode Island to the list of states that will no longer receive Eli Lilly’s Covid-19 monoclonal antibody combo treatment due to an elevated frequency of concerning variants.
Combined frequencies of the Gamma (or P.1) variant first identified in Brazil and the Beta (B.1.351) variant first identified in South Africa now exceed 10% in Rhode Island and are trending upward, according to the CDC. And results from in vitro assays, using “pseudo-virus particles,” suggest that Eli Lilly’s bamlanivimab and etesevimab combination isn’t active against either variant.
As a result, the assistant secretary for preparedness and response (ASPR) is pausing the distribution of bamlanivimab and etesevimab — and etesevimab alone, to pair with an existing supply of bamlanivimab at one facility — to Rhode Island “until further notice.” The government has already slammed the brakes on distribution to Arizona, California, Florida, Illinois, Indiana, Massachusetts, Oregon and Washington, where the frequency of the Gamma and Beta variants has also surpassed 10%.
Back in March, the US government and Eli Lilly agreed to halt all distribution of bamlanivimab alone due to the “sustained increase” of coronavirus variants countrywide. However, all treatment delivery sites were still able to order Lilly’s combo treatment, or Regeneron’s antibody cocktail, the ASPR and FDA said.
Going forth, the ASPR said healthcare providers in the previously mentioned states should rely on Regeneron’s REGEN-COV and GlaxoSmithKline’s sotrovimab, which are “likely to retain activity” against the Gamma and Beta variants.
“ASPR and FDA will continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the monoclonal antibody therapies authorized for emergency use,” the ASPR said in an announcement.
Hundreds of health workers who received Sinovac’s vaccine are infected with Covid-19 — report
Despite receiving Sinovac’s Covid-19 vaccine, more than 350 medical workers in Indonesia have been infected with the virus, according to Reuters.
The shot — which was just effective enough to meet regulatory standards — was given the World Health Organization’s OK for emergency use earlier this month. It’s also the first Chinese Covid-19 vaccine to be considered by the European Medicines Agency, which kicked off a rolling review of the inactivated vaccine back in May.
Badai Ismoyo, head of the health office in Kudus, said most of the workers are asymptomatic, but dozens have been hospitalized, according to Reuters. And across the whole country, at least six health workers have died from Covid-19 after receiving the vaccine (one of them had only received a first shot).
The outbreak is believed to be caused by the Delta variant, first identified in India, Reuters reported.
Upon filing for conditional market authorization with China’s National Medical Products Administration back in February, Sinovac said that trial results from Brazil and Turkey suggested the shot prevented 50.65% of all Covid-19 cases, 83.70% of cases requiring medical treatment, and 100% of hospitalizations, and severe or fatal cases 14 days after the second dose was administered.
Australia pushes age limit for AstraZeneca’s vaccine to 60
Months after limiting the use of AstraZeneca’s vaccine to people over 50 years old, Australia is now pushing the age limit to 60, Reuters reported.
The move follows the deaths of two people who had received the vaccine, Australia’s Minister for Health Greg Hunt told Reuters. Sixty cases of blood clots have been linked to the vaccine, out of 3.3 million doses administered in the country, he said.
“This updated advice received today is based on new evidence demonstrating a higher risk for the very rare (thrombocytopenia syndrome) condition in the 50-59 year-old age group,” Hunt said, per Reuters.
It marks the latest restriction around AstraZeneca’s shot following a series of safety concerns. After conducting an in-depth review of cerebral venous sinus thrombosis (CVST) and splanchnic vein thrombosis cases back in April, the EMA concluded that very rare but sometimes fatal blood clots should be listed as a side effect for AstraZeneca’s Covid-19 vaccine. However, a number of countries have moved to restrict the vaccine’s use to people under a certain age.
Germany said back in March that it would stop using the vaccine in people under 60 years old, and in April the Philippines followed suit. That same week, the French health regulator Haute Autorité de Santé said patients under 55 who had received the first dose of AstraZeneca’s vaccine should get their second dose from one of Pfizer/BioNTech or Moderna’s mRNA-based shots. Officials recommended a 12-week interval between each dose.
In May, the UK’s Joint Committee on Vaccination and Immunisation called to restrict the use of the vaccine to only those who are over 40 years old.
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