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The FDA will up­date the fact sheets for the Pfiz­er/BioN­Tech and Mod­er­na Covid-19 vac­cines, af­ter the CDC ad­vi­so­ry group ACIP found that rare cas­es of heart in­flam­ma­tion in ado­les­cents and ...


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.

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Covid-19 roundup: Re­al world da­ta sug­gest As­traZeneca vac­cine ef­fec­tive against Delta, Al­pha vari­ants; No­vavax hails pos­i­tive study on coro­n­avirus, flu shots com­bo

AstraZeneca’s Covid-19 vaccine, which has been authorized for use in the EU and Japan among many countries but not yet the US, has proved effective against the Delta variant, the company announced on Tuesday.

Real world data from Public Health England showed that the vaccine conferred high levels of protection against the variant that originated in India, as its 2 doses demonstrated 92% efficacy against hospitalization due to this variant. For the Alpha variant, which originated in the UK, the vaccine spurred a 86% reduction in hospitalization, with no deaths reported.

As­traZeneca's Covid-19 an­ti­body cock­tail miss­es the mark in pre­vent­ing symp­toms post-ex­po­sure

As the field for monoclonal antibody treatments of Covid-19 grows more crowded, AstraZeneca has announced a study of its own cocktail AZD7442 did not meet its main goal of preventing symptomatic Covid-19.

The company’s long-acting antibody combo was used in a trial with unvaccinated adults about the age of 18 with confirmed exposure. AZD7442 reduced the risk by just 33%, a figure that was not statistically significant.

Covid-19 roundup: Ger­many puts J&J on the hot­seat for vac­cine back­o­rder; Top EMA of­fi­cial sug­gests for­go­ing As­traZeneca shot

Shortly after it was announced that the FDA has required J&J to discard tens of millions of Covid-19 vaccines that were contaminated at an embattled Emergent plant in Baltimore, MD, Germany has demanded that the company deliver 6.5 million doses to make up for a shortfall, Reuters reported.

The FDA said Friday that two batches of the drug substance used in J&J’s jab would be released from quarantine after millions of doses were held from distribution at the Emergent site. While that frees up about 10 million doses, The New York Times reported Friday morning another 60 million doses were ordered to be tossed out.

75M vac­cine dos­es wast­ed: FDA spells out Emer­gent fa­cil­i­ty de­fi­cien­cies at length in new memo

The FDA is offering a fuller account of what went wrong at Emergent BioSolutions’ Covid-19 manufacturing facility in Baltimore, where the cross contamination of J&J and AstraZeneca vaccines led to the discarding of about 75 million vaccine doses.

CBER director Peter Marks released a memo on Saturday with new specifics, making clear up front that no vaccine manufactured at this plant has been distributed for use in the US yet.

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UP­DAT­ED: Long-await­ed No­vavax PhI­II re­sults show 90.3% over­all ef­fi­ca­cy, with 100% ef­fec­tive­ness against mod­er­ate and se­vere Covid-19

After several months of delays and setbacks, the small Maryland biotech Novavax has finally completed its North American Phase III trial for its Covid-19 vaccine. And though they say the topline results are positive, it remains to be seen how much uptake there will be in the US given the waning numbers of cases, rising vaccination rates and a surplus of already-authorized vaccines.

Overall efficacy in the study hit 90.3% across nearly 30,000 patients in the US and Mexico, Novavax said, with a total of 77 cases observed. In the placebo arm, researchers saw 63 cases of Covid-19 compared to 14 in the vaccine group. Participants were randomized into the vaccine arm 2 to 1, and Novavax said it collected its data between Jan. 25 and April 30.

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As it ex­pands its foot­print, Mod­er­na reach­es deal to com­mer­cial­ize Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to commercialize its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.

Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.