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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…

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.

Get the full story from our sister site, Drug Discovery & Development.

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 …

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.

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.

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…

MedTech 100 roundup: New heights reached again

One week after recording its all-time best performance, the medtech industry once again topped itself, storming even further ahead.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has been on the rise since April began, with last week’s mark of 112.25 (April 16) representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index has already bested itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week.

The rapid improvement continues to shine a light on the strong position the industry has maintained more than a year on from the height of the COVID-19 pandemic’s impact on medtech. The industry has produced a 24.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 84.4% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall markets fared di…

Roche retools COVID-19 strategy

The Swiss pharma giant Roche (OTCMKTS:RHHBY) has canceled two Phase 2 COVID-19 studies while looking to identify a new site to conduct a clinical study for the oral antiviral AT-527, which it is developing with Atea Pharmaceuticals (NSDQ:AVIR.O). The two companies were looking to launch a trial in the U.K., but falling COVID-19 cases there have complicated recruitment.

“There’s just simply not enough patients to enroll with the speed we were hoping for,” said Bill Anderson, head of Roche’s pharmaceutical division, in a conference call.

Roche and Atea hoped AT-527 would offer a more convenient alternative to intravenous treatments such as antibody cocktails or Gilead Science’s (NSDQ:GILD) remdesivir.

One of the two canceled Phase 2 studies was for the monoclonal antibody astegolimab (RG6149), which the company had licensed from Amgen (NSDQ:AMGN).

The other Phase 2 trial Roche halted related to RG7880 (efmarodocokin alfa), which the company hoped…

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.

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…

Why demand for J&J and AstraZeneca COVID-19 vaccines remains unclear

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

After the European Medicines Agency determined that the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, the company announced that it would unfreeze its European vaccinate rollout. But assessing demand for the J&J and AstraZeneca vaccines remains difficult. The possible link to rare blood clots could elevate the role of vaccines from Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and others.

The European Medicines Agency (EMA) did, however, advise that the vaccine bear a warning describing a risk of rare blood clots.

Although the J&J vaccine had been authorized in the E.U., nations there have not yet used it. After U.S. authorities paused the use of the vaccine, Johnson & Johnson decided to suspend the distribution of the product voluntarily.

…

mRNA vaccine led to shingles in a handful of immunocompromised patients

Electron micrograph of the varicella-zoster virus. Image courtesy of CDC.

A group of researchers in Israel has concluded that a mRNA-based vaccine could activate herpes zoster (shingles) in a limited number of people with rheumatic diseases.

The viral infection, which can cause a painful rash, is caused by the varicella-zoster virus, which is also responsible for chickenpox.

In a study focusing on individuals with autoimmune inflammatory rheumatic diseases (AIRD), researchers at the Tel Aviv Sourasky Medical Center and Carmel Medical Center in Haifa followed 491 patients and 99 controls. A total of six patients with AIIRD, or 1.2%, had a reactivation of herpes zoster after vaccination with the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

No patients in the control arm developed shingles in the study published in Rheumatology.

The researchers acknowledged that the st…