Pfizer Says Xeljanz Reduced Deaths and Lung Failure Among Hospitalized Covid-19 Patients; US halts distribution of Eli Lilly’s mAb combo in Rhode Island due to variants – Endpoints News

In addition to its ultra-effective mRNA vaccine, Pfizer believes it has another weapon at its disposal to fight the Covid-19 pandemic.

The company announced on Wednesday that its rheumatoid arthritis blockbuster Xeljanz has significantly reduced 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 several treatment options to treat patients who have contracted the virus,” Tamas Koncz, chief marketing officer of Pfizer Inflammation & Immunology, said in a statement.

The trial – conducted in collaboration with the Academic Research Organization (ARO) at Israelita Albert Einstein Hospital in Sao Paulo, Brazil – included 289 hospitalized adults who were not on ventilation. Most patients (89.3%) also used glucocorticoids during hospitalization, mainly dexamethasone.

Patients in the treatment arm received two doses of 10 mg per day, for up to 14 days or until discharge from hospital. On day 28, death or respiratory failure occurred in 18.1% of Xeljanz patients, compared to 29% in the placebo group (p = 0.04). All-cause deaths up to day 28 were 2.8% in the Xeljanz group and 5.5% in the placebo group.

Regarding 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 data set for this study and assess next steps,” Koncz said.

US halts distribution of Eli Lilly’s mAb combo in Rhode Island due to variants

The U.S. government is adding Rhode Island to the list of states that will no longer receive Eli Lilly’s combination Covid-19 monoclonal antibody treatment due to a high frequency of worrisome variants.

The combined frequencies of the Gamma variant (or P.1) first identified in Brazil and the Beta variant (B.1.351) first identified in South Africa now exceed 10% in Rhode Island and tend to increase. increase, according to the CDC. And the results of in vitro tests, using ‘virus-like particles’, suggest that Eli Lilly’s bamlanivimab and etesevimab combination is not active against any of the variants.

As a result, the Assistant Secretary of Preparedness and Response (ASPR) is suspending distribution of bamlanivimab and etesevimab – and etesevimab alone, to combine with an existing supply of bamlanivimab at one facility – in Rhode Island. ” until further notice”. The government has already curbed distribution in Arizona, California, Florida, Illinois, Indiana, Massachusetts, Oregon and Washington, where the frequency of the Gamma and Beta variants has also exceeded 10%.

In March, the US government and Eli Lilly agreed to stop all distribution of bamlanivimab alone due to the “sustained increase” in coronavirus variants across the country. However, all treatment delivery sites were still able to order Lilly’s combination therapy or the Regeneron antibody cocktail, the ASPR and FDA said.

Going forward, ASPR said healthcare providers in the aforementioned states should rely on REGEN-COV from Regeneron and sotrovimab from GlaxoSmithKline, which are “likely to remain active” against Gamma and Beta variants.

“The ASPR and the FDA will continue to work with the CDC and the National Institutes of Health on monitoring for variants that may impact the use of monoclonal antibody therapies authorized for emergency use,” said the ASPR in a press release.

Hundreds of health workers who received Sinovac 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 – received World Health Organization clearance for emergency use earlier this month. It is also the first Chinese Covid-19 vaccine to be considered by the European Medicines Agency, which launched an ongoing review of the inactivated vaccine in May.

Badai Ismoyo, head of the Kudus health unit, said most of the workers are asymptomatic, but dozens have been hospitalized, according to Reuters. And across the country, at least six health workers have died from Covid-19 after receiving the vaccine (one of them had only received a first injection).

The outbreak is believed to be caused by the Delta variant, first identified in India, Reuters reported.

When filing for a conditional marketing authorization with China’s National Medicines Administration in February, Sinovac said test results from Brazil and Turkey suggested the shooting 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 administration of the second dose.

Australia pushes back age limit for AstraZeneca vaccine to 60

Months after limiting use of AstraZeneca’s vaccine to people over 50, Australia is now pushing back the age limit to 60, Reuters reported.

The move follows the deaths of two people who had received the vaccine, Australian Health Minister 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 of a very rare disease (thrombocytopenia syndrome) in the 50-59 age group,” Hunt said, per Reuters.

This is the latest restriction around AstraZeneca’s shooting following a series of safety concerns. After performing a thorough review of cases of cerebral venous sinus thrombosis (CVST) and splanchnic vein thrombosis in April, the EMA concluded that very rare but sometimes fatal blood clots should be listed as a side effect of the Covid vaccine. -19 from AstraZeneca. However, a number of countries have decided to restrict the use of the vaccine to people under a certain age.

Germany said in March it would stop using the vaccine in people under the age of 60, and in April, the Philippines followed suit. That same week, the French health regulator, the Haute Autorité de Santé, said patients under 55 who received the first dose of AstraZeneca vaccine should receive their second dose of one of the vaccines at mRNA base from Pfizer / BioNTech or Moderna. Authorities have recommended an interval of 12 weeks between each dose.

In May, the UK’s Joint Committee on Vaccination and Immunization called for restricting the use of the vaccine to people over the age of 40.

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