New therapy could protect lung function in COVID-19 and flu patients

[Image courtesy of CDC]

One of the most dangerous aspects of the novel coronavirus is its potential to cause pneumonia and acute respiratory distress syndrome (ARDS). Pandemic influenza A (H1N1) can cause similar problems.

A team of researchers at Ohio State University has developed a potential treatment for ARDS stemming from COVID-19 or influenza.

The inspiration for the therapy, which they tested in mice, resulted in an observation that influenza-infected mice had lower levels of liponucleotides, which are involved in the production of surfactant in the lungs. Pulmonary surfactants support normal lung function, preventing them from partially or fully collapsing.

The researchers administered liponucleotides to influenza-infected mice via both injection and orally. Their blood oxygen levels returned to normal while inflammation decreased.

“The most important and impressive thing in this …

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Study: Single dose of Pfizer or AstraZeneca COVID-19 vaccine cuts infection risk by 65%

[Photo by Daniel Schludi on Unsplash]

One dose of vaccine from Pfizer (NYSE:PFE) or AstraZeneca (LON:AZN) leads to a substantial reduction in infection risk in adults, according to a recent study published in BMJ. 

The study organizers found that recipients of a single dose of either vaccine led to a 57% reduction in asymptomatic infections and a 74% drop in symptomatic disease at least 21 days after vaccination. The overall risk reduction was thus 65%. 

A second dose of the vaccine from Pfizer and its partner BioNTech (NSDQ:BNTX) reduced the risk of infection by 70% in the study. There was insufficient data to assess the efficacy of the AstraZeneca vaccine after the second dose. 

The researchers concluded that when vaccine supplies are limited, health systems should prioritize vaccinating those who have not yet been infected with COVID-19 while prioritizing giving second doses to those 60 and o…

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U.S. to donate 60M doses of AstraZeneca’s COVID-19 vaccine

The Biden administration announced today that it will begin sharing its store of AstraZeneca’s COVID-19 vaccine following safety reviews.

Once the vaccine clears federal safety reviews, 60 million doses of the vaccine are expected to be made available, according to a Tweet from senior White House advisor Andy Slavitt.

“BREAKING: U.S. to release 60 million Astra Zeneca doses to other countries as they become available,” Slavitt wrote on the social media platform.

Get the full story at our sister site, Pharmaceutical Processing World.

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U.S. to donate 60M doses of AstraZeneca’s COVID-19 vaccine

The Biden administration announced today that it will begin sharing its store of AstraZeneca’s COVID-19 vaccine following safety reviews.

Once the vaccine clears federal safety reviews, 60 million doses of the vaccine are expected to be made available, according to a Tweet from senior White House advisor Andy Slavitt.

“BREAKING: U.S. to release 60 million Astra Zeneca doses to other countries as they become available,” Slavitt wrote on the social media platform.

He followed the initial announcement with a reply, saying “to everyone who understandably says: ‘about time’ or ‘what were they waiting for’, at this time there are still very few available. No real time has been lost.”

The Associated Press, which was first to report the news, said the decision expands upon Biden’s earlier promise to share 4 million doses of the vaccine with Mexico and Canada.

According to the AP report, th…

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More than 5 million skipped getting second COVID-19 vaccine dose

Image courtesy of Wikipedia

The percentage of people who failed to get the second dose of Pfizer or Moderna COVID-19 vaccines is growing, according to recent CDC data. Some five million people, or almost 8% of people who got the first vaccine dose, missed getting the second.

In mid-March, 3% of people were overdue for their second dose.

People who missed getting their second vaccine dose provided several explanations. Some wanted to avoid adverse events, which are more common after the second dose. Others believed a single dose offered sufficient protection.

Get the full story from our sister site, Pharmaceutical Processing World. 

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More than 5 million skipped getting second COVID-19 vaccine dose

Pfizer-BioNTech vaccine image courtesy of Wikipedia

The percentage of people who failed to get the second dose of Pfizer or Moderna COVID-19 vaccines is growing, according to recent CDC data. Some five million people, or almost 8% of people who got the first vaccine dose, missed getting the second.

In mid-March, 3% of people were overdue for their second dose.

People who missed getting their second vaccine dose provided several explanations. Some wanted to avoid adverse events, which are more common after the second dose. Others believed a single dose offered sufficient protection.

Another contributing factor relates to supply constraints at vaccination sites, which are instructed not to use Moderna and Pfizer vaccines interchangeably.

The supply constraints are likely to ease the number of people making appointments for COVID-19 vaccination falls in many parts of the country.

Som…

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Israel investigating heart inflammation cases in Pfizer COVID-19 vaccine recipients

Histopathology of myocarditis. [ Image courtesy of Wikipedia]

Israel’s Health Ministry is researching “tens” of cases of myocarditis, or heart inflammation, in people who have received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

More than five million people in the country have received the vaccine.

The agency, however, has not yet established a causal relationship between the events and the vaccine.

Pfizer has also reported that it has not observed a higher rate of myocarditis among vaccine recipients than in the general population.

The Israeli data suggest that myocarditis reports may be more common after the second vaccine dose.

Most of the people with myocarditis were 30 years old or younger.

Establishing causation for myocarditis can be challenging. Researchers have linked the condition to an array of pathogens, including viruses, bacteria and …

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FDA, CDC lift pause on J&J COVID-19 vaccine

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

Get the full story at our sister site, Pharmaceutical Processing World.

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FDA, CDC lift pause on J&J COVID-19 vaccine

This 2020 image shows a vial of J&J vaccine when it was investigational. Image from Johnson & Johnson.

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

Get the full story at our sister site, Pharmaceutical Processing World.

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FDA, CDC lift pause on J&J COVID-19 vaccine

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

Following a safety review that included two meetings of the CDC’s Advisory Committee on Immunization Practices, the pause was lifted on Friday, April 23, according to a news release Medical and scientific teams at the FDA and CDC examined available data to evaluate the risk of the form of blood clot known as cerebral venous sinus thrombosis (CVST) that was seen in combination with low levels of blood platelets (thrombocytopenia).

The two agencies concluded that use of the vaccine can resume…

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FDA releases scathing inspection report regarding Emergent BioSolutions plant

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca.

The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch.

Emergent Biosolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

Get the full story from our sister site, Pharmaceutical Processing World. 

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FDA releases scathing inspection report regarding Emergent BioSolutions plant

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca.

The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch.

Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

It is possible that other batches of vaccine need to be discarded. “There is no assurance that other batches have not been subject to cross-contamination,” the FDA concluded.

“The issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations. Emergent is committed to workin…

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