COVID-19 vaccine trial Archives - Page 6 of 13

J&J COVID-19 vaccine protects against Delta variant

Johnson & Johnson (NYSE:JNJ) has announced that a single shot of its COVID-19 vaccine offers significant protection against the transmissible Delta variant. The vaccine also provides an immune response lasting at least eight months.

The announcement coincides with the company filing two preprint studies to bioRxiv. The first analyzes blood samples from eight patients in the company’s Phase 3 ENSEMBLE study, which it used to win emergency use authorization in the U.S. That study concluded that a single dose of the vaccine led to a higher neutralizing antibody activity against the Delta variant than the Beta variant (B.1.351) that first emerged in South Africa.

Rival Moderna is developing a vaccine known as mRNA-1273.351 based on the Beta variant.

J&J also announced that its vaccine elicited a robust immune response to other common SARS-CoV-2 variants.

The company also said that its vaccine led to a strong neutralizing antibody response that…

CureVac aims to rebound after announcing disappointing COVID-19 results

Some two week after announcing that its COVID-19 vaccine had an interim efficacy of 47% in a Phase 2b/3 trial, CureVac (NSDQ:CVAC) appears to be regaining its footing.

While its stock is trading well below its Feb. 5 peak of $120.43, CVAC shares have risen 30% in the past five days to $75.95 in mid-day trading today.

The company is installing a new chief operating officer, Dr. Malte Greune, who will begin work on July 1, 2021.

Greune will work to bolster CureVac’s board and clinical and manufacturing capabilities.

Greune joins CureVac from Sanofi where he worked in an executive business development role. Gruene has held various leadership positions at pharma companies in the past decade.

Earlier this month, CureVac cofounder Ingmar Hoerr withdrew his candidacy for nomination to the company’s board. Hoerr also served as the company’s CEO from March to August 2020

CureVac has also charged another co-founder, Florian von der…

Moderna’s COVID-19 vaccine holds its own against Delta variant in study

A small study indicated that Moderna’s messenger RNA COVID-19 vaccine was effective against the Delta variant.

Using serum samples from eight Phase 1 participants drawn one week after administering the second dose of the vaccine, the analysis found a 2.1-fold reduction in neutralizing titers against the Delta (B.1.617.2) variant relative to the ancestral strain of the virus.

The World Health Organization has urged the public — including the fully vaccinated — to continue wearing masks and practice social distancing to reduce the spread of the Delta variant.

In related news, Moderna’s COVID-19 also won emergency use authorization in India, where scientists first identified the Delta variant.

The variant is gaining traction in the U.S. and will likely gain dominance in the coming weeks.

The vaccine appears to also offer protection against the Beta (B.1.351), Gamma (P.1), Kappa (B.1.617.1) and Eta (B.1.525) variants, although the reduction in…

Pfizer-AstraZeneca COVID-19 vaccine combinations are effective, study suggests

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

British researchers report that using distinct COVID-19 vaccine types for the first and second doses appears to be effective, according to a preprint study in The Lancet.

As global health authorities seek to vaccinate as many people as possible, a potential hurdle is the need to use identical vaccines for the prime and boost stages. Using a so-called heterologous prime-boost vaccination would enable more rapid vaccination, but data about the efficacy of such a strategy have been scarce.

In the recent study, researchers randomized 830 adults 50 and older into eight groups to receive the varying combinations of the AstraZeneca and BioNTech-Pfizer vaccines.

To get a sense of the efficacy of the various combinations, the researchers used a geometric mean ratio (GMR) and geometr…

FDA plans to warn of rare myocarditis risk following COVID-19 vaccination

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39.

The conditions appear to be more common in males.

The FDA warning will state that health officials have observed myocarditis or pericarditis in a limited number of people after receiving the second vaccine dose. The onset of symptoms usually occurred within several days to a week. The warning will recommend that people with post-vaccination myocarditis or pericarditis symptoms seek medical care.

Federal officials, however, continue to stress that the benefits of the mRNA vaccines clearly outweigh the risks. In an HHS statement, multiple health officials from the public and private sector stress that the heart issue is “an extremely rare side effect, and only an exc…

Europe orders another 150 million doses of Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) has announced that the European Commission has reserved an additional 150 million doses of its COVID-19 vaccine for delivery in 2022.

To date, the European Commission has reserved 460 million Moderna vaccine doses.

The new deal gives the European Commission the ability to purchase new COVID-19 vaccines.

The company is currently testing various booster options, including the use of its existing mRNA-1273 vaccine. In addition, it is developing a vaccine known as mRNA-1273.351 based on the B.1.351 variant that first emerged in South Africa.

Interim data from a Phase 2 trial in the U.S. found that both mRNA-1273 and mRNA-1273.351 led to increased neutralizing antibody titer levels in response to the B.1.351 and P.1 variants. The mRNA-1273.351 appears to be more effective at generating an immune response to those viral lineages. The P.1 variant is also known as the “Gamma Variant.”

Moderna also recently announced that the…

mRNA vaccines do not negatively affect sperm county, study finds

One of the many urban legends related to COVID-19 vaccines is that they cause infertility. Researchers at the University of Miami set out to disprove that claim with a recent single-center prospective study. Unsurprisingly, the study that indicated the mRNA vaccines have no negative impact on male fertility. In fact, the researchers found that after the second vaccine dose, participants exhibited a significant increase in median sperm concentration and sperm motility.

In the study published in JAMA, the researchers stopped short of claiming that mRNA COVID-19 vaccines could boost fertility in men. “While these results showed statistically significant increases in all sperm parameters, the magnitude of change is within normal individual variation,” the study authors concluded.

The study only evaluated the BNT162b2 and mRNA-1273 vaccines from Pfizer-BioNTech and Moderna, respectively.

The study tracked participants approximately 70 days after administering…

CureVac marches on after announced disappointing study results

After CureVac (NSDQ:CVAC) revealed that its first-generation vaccine candidate has an interim efficacy of 47% in a pivotal trial, its stock lost about half its value. The company, however, is undeterred.

Speaking in a call with investors and analysts, CureVac CEO Franz-Werner Haas said the company would continue to seek the authorization of its CVnCoV vaccine and continue developing its next-generation CV2CoV vaccine.

One difference between the vaccine from CureVac and those from Moderna and Pfizer-BioNTech lies in the dose of mRNA. The CureVac vaccine contains 12 µg of mRNA per dose. The Pfizer-BioNTech vaccine uses 30 µg per shot, while the Moderna vaccine contains 100 µg.

Haas, however, stressed the role of virus variants in the 47% interim efficacy figure. The Phase 2b/3 study “provides important insights into a dramatically transformed variant environment, suggesting that we are virtually fighting a different virus — a different pandemic” than six m…

U.S. buys 200 million more Moderna vaccine doses for potential boosters and use in children

Health experts remain divided over the need for COVID-19 vaccine boosters in the coming months, but the U.S. government is preparing for that possibility by purchasing 200 million additional doses of the COVID-19 vaccine from Moderna (NSDQ:MRNA).

The purchase of additional doses will also enable the U.S. government to inoculate children aged 12 to 17 in coming months, assuming FDA authorizes that use. Two doses of the vaccine were 100% effective in that age group, according to a recent Phase 2/3 trial.

In May, FDA amended its EUA for the Pfizer-BioNTech vaccine to include adolescents aged 12 to 15.

The U.S. has committed to buying 500 million doses of Moderna’s vaccine to date. The company expects to deliver 110 million doses in the fourth quarter of 2021 and another 90 million in the first quarter of 2022.

To date, Moderna has provided 217 million doses to the U.S.

The NIH has launched a clinical trial involving fully vaccinated participan…

CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

CureVac’s stock dropped 3.47% to $94.79 per share after the company announced the news.

The company anticipates that a final analysis will be ready in a matter of weeks. Based on available data, the vaccine appears to have a favorable safety profile.

CureVac is partnering with GSK (NYSE:GSK) to develop a next-gen COVID-19 vaccine. That vaccine could potentially protect against multipl…

Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

In related news, Pfizer and BioNTech must contend with concerns that their BNT162b2 could be linked to myocarditis in adolescents.

[Related: 50 of 2020’s best-selling pharmaceuticals]

A recently published preprint in the journal Pediatrics describes seven male adolescents who developed myocarditis after receiving the vaccine. All seven pa…

Almost one-quarter of Americans remain vaccine-hesitant

[Photo by Maksim Goncharenok from Pexels]

A study from Informa Pharma Intelligence and YouGov concluded that vaccine hesitancy remains a significant hurdle in the U.S. A separate study published in JAMA indicates vaccine hesitancy is falling. Specifically, the number of people who were suspicious about COVID-19 vaccines fell from 46% in October 2020 to 35% in March 2021.

Conversely, the Informa-YouGov survey from April 21 and 22 concluded that 23% of Americans were vaccine-hesitant. The study had 1,327 adult participants.

While approximately half of the U.S. public has received at least one vaccine dose, vaccinating the remainder of the eligible population could be a hurdle.

But the recent data from the Informa-YouGov survey indicate that achieving President Biden’s goal of providing at least one vaccine dose to 70% of the American adults by July 4 is at least feasible.

Another factor tha…