President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine.
The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week.
Get the full story at our sister site, Pharmaceutical Processing World.
President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine.
The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week.
Get the full story at our sister site, Pharmaceutical Processing World.
President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine.
The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week.
According to the report, anonymous officials told The Post that, upon the realization that J&J was behind on vaccine production in the early days of the Biden administration, they began looking for additional manufacturing capacity, landing on Merck as an option after the company was unable to produce its own COVID-19 vaccine.
Merck is set to provide two U.S. facilities for producing J&J vaccine doses, with one offering fill-finish services and the other actually making the vaccine. According to the report, this could potentially double the production capacit…
Photo by Elly Fairytale from Pexels
More than half a million people in Moscow have received the first dose of COVID-19 vaccine or about 4% of its population. Now, Russia is aiming to both ramp up domestic vaccinations and exports of its Sputnik V vaccine.
Moscow has been one of the few cities that has had a surplus of COVID-19 vaccine.
Now, some 12,000 to 20,000 residents sign up daily for the vaccines, according to the Department of Information Technologies of Moscow.
The Russian capital has a population of 12.7 million.
The country’s two-dose Sputnik V vaccine has an efficacy of 91.6%, according to interim trial results.
Moscow is administering the vaccines with a network of 100 clinics and 20 public places with mobile vaccinators.
A growing number of categories of Moscow residents are eligible for the vaccine, which includes people over the age of 60, retirement-ho…
Image from Nataliya Vaitkevich via Pexels
One adverse event common to clinical trials for currently authorized COVID-19 vaccines is Bell’s palsy, an asymmetrical weakness or paralysis of the face that is often temporary.
Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group. Another patient developed facial swelling and “droopiness” without facial asymmetry. A clinical trial investigator concluded that this event was unrelated to the vaccine.
Three vaccine recipients in the Moderna Phase 3 clinical trial developed Bell’s palsy, as did one in the placebo group. In the corresponding Pfizer-BioNTech study, four vaccine recipients developed Bell’s palsy, but no participants in the placebo group did.
The three Phase clinical trials involved some 30,000 to 40,000 volunteers.
The numerical imbalance between the …
Americans will start receiving Johnson & Johnson‘s COVID-19 vaccine within the next 24 to 48 hours, J&J CEO Alex Gorsky told NBC’s Today this morning.
FDA issued an EUA for J&J’s Ad26.COV2-S vaccine on Feb. 27, a day after an advisory panel unanimously recommended that the agency authorize the vaccine for adults 18 and over. J&J’s vaccine is the third COVID-19 vaccine to receive authorization in the U.S. so far.
Get the full story from our sister publication, Drug Discovery & Development.
The U.S. is poised to have three vaccines available after an FDA advisory panel unanimously recommended that the agency authorize the Ad26.COV2-S vaccine from Johnson & Johnson for adults 18 and over.
Although the recommendations of the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) are nonbinding, the agency almost always heeds them. There are 22 members in the panel.
Get the full story at our sister site, Drug Discovery & Development.
The U.S. is poised to have three vaccines available after an FDA advisory panel unanimously recommended that the agency authorize the Ad26.COV2-S vaccine from Johnson & Johnson.
Although the recommendations of the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) are nonbinding, the agency almost always heeds them. There are 22 members in the panel.
The agency will likely authorize the vaccine quickly.
J&J’s vaccine differs from the mRNA vaccines currently available in that it uses an adenovirus vector, will be available as a single dose and can be stored at typical refrigeration temperatures.
While the vaccine’s overall efficacy of 66% trails that of vaccines from Pfizer and Moderna by nearly 30 percentage points, the vaccine offers strong protection against severe COVID-19 disease.
VRBPAC member Dr. Archana Chatterjee shed light on the panel’s unanimous support of the vaccine, even though some member…
In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears.
In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer.
No placebo recipients developed the condition.
Get the full story from our sister site, Drug Discovery & Development.
[Photo by Praveen Kumar Nandagiri on Unsplash]
Health Canada today announced the authorization of the COVID-19 vaccine developed by AstraZeneca and Oxford University — the third vaccine for the novel coronavirus authorized in Canada.“This is very encouraging news. It means more people vaccinated, and sooner. Because for AstraZeneca, just like we were for Pfizer and Moderna, we are ready to get doses rolling,” said Prime Minister Justin Trudeau, as recounted by CBC.
“Vaccines will keep arriving faster and faster as we head into the spring,” Trudeau said.
The Health Canada decision came after two studies — involving 11,636 participants in the U.K. and Brazil — showed an efficacy rate of 62.1% after two standard doses. The efficacy rate was 59.5% in an updated analysis in which the second dose was administered 4 to 12 weeks after the first dose.
On top of the AstraZe…
Moderna Logo (PRNewsFoto/Moderna Therapeutics)
Moderna posted mixed fourth-quarter results today with a larger-than-expected loss but beat the consensus forecast for revenue. The company boosted its outlook for the rest of the year, citing strong demand and maturing commercialization capabilities.
The Cambridge, Mass.-based vaccine developer reported revenue of $570.7 million for the three months ended Dec. 31, 2020. That figure was well ahead of the consensus estimate of $326.58 million. Revenue in the same period of 2019 was $14 million.
The company reported a loss of $272.5 million in its fourth quarter. That equated to a loss per share of –$0.69. Analysts had expected a loss of –$0.25. The company had a loss of $0.34 per share a year ago.
“2020 was a historic year for Moderna,” said the company’s CEO, Stéphane Bancel, in an earnings call. Beginning the year as “an early-stage development co…
The FDA announced today that it is allowing undiluted, frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored for up to two weeks at conventional temperatures commonly found in pharmaceutical freezers.
The decision should allow for wider distribution of the vaccine to sites that do not have ultra-low temperature freezers.
Get the full story on our sister site, Medical Design & Outsourcing.