COVID-19 vaccines Archives - Page 9 of 24

Full COVID-19 vaccination could ultimately mean three doses

Dr. Anthony Fauci

While mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) had 95% efficacy in Phase 3 clinical trials, their effectiveness in the real world has dropped with the rise of the Delta variant.

As a result, breakthrough infections have grown more common in people who have received two doses of mRNA vaccines.

Ultimately, full vaccination may require three doses, concluded Chief Medical Advisor to the President Dr. Anthony Fauci in a press briefing. While acknowledging that the FDA would need to make the final decision, “I must say from my own experience as an immunologist, I would not at all be surprised that the adequate full regimen for vaccination will likely be three doses,” Fauci said.

In the briefing, Fauci pointed to booster data emerging from Israel recently published in a preprint. The Pfizer-BioNTech vaccine led to a 70% to 84% risk reduction 14 days after admin…

U.S. vaccination rates tick up after Pfizer vax approval

Photo by Frank Meriño from Pexels

The number of daily vaccinations in the U.S. has steadily increased since early June with the rise of the Delta variant.

FDA’s decision to approve the Pfizer-BioNTech vaccine, the first to win that status, on August 23 appears to have hastened vaccinations further. Vaccinations have increased by 17% after that decision.

In particular, the approval appears to have fueled an uptick in the number of people obtaining the first dose of vaccine.

According to an Axios/Ipsos survey, the approval has led to a decrease in vaccine hesitancy, with two out of 10 Americans stating they were unlikely to pursue vaccination, according to an Axios/Ipsos survey. Earlier in the year, the number of vaccine-hesitant Americans was twice as high.

A growing number of U.S. companies are supporting vaccine mandates, with more than half of U.S. companies planning on requiring vacci…

Could COVID-19 vaccines guard against dementia?

COVID-19 vaccines could potentially guard against dementia and Alzheimer’s disease, according to an op-ed in WSJ.

COVID-19 infection itself can lead to long-term cognitive decline in some individuals and can accelerate Alzheimer’s symptoms, concluded an Alzheimer’s Association study. An Alzheimer’s Research & Therapy echoed those findings.

Pointing to data suggesting that vaccinations against tetanus and flu lead to reduced Alzheimer’s incidence in seniors, the WSJ article notes that a systemic immune response from vaccines could lower brain inflammation and thus protect brain neurons.

The thesis is not new. For example, a 2001 study in the Canadian Medical Association Journal theorized that prior vaccination against diphtheria or tetanus, poliomyelitis and influenza could protect against Alzheimer’s disease.

And last July, the Alzheimer’s Association published a study making similar claims. Researchers have correlated flu and pneumonia vac…

Study finds Moderna’s COVID-19 vaccine drives a stronger antibody response than Pfizer’s

Research published in JAMA found the Moderna’s COVID-19 vaccine drove an antibody response that was more than two times greater than that of Pfizer’s.

Specifically, the Moderna mRNA-1273 vaccine generated post-second-dose antibody levels of 2,881 units per milliliter. Those who received the Pfizer-BioNTech BNT162b2 vaccine had antibody levels measuring 1,108 units per milliliter.

The study involved 1,647 fully vaccinated healthcare workers in Belgium.

Immune protection, however, involves more than antibody levels. Pfizer researchers found that recipients of their vaccine have immune protection 12 days after vaccination when there are low antibody levels, according to a STAT article.

In volunteers who had previously contracted COVID-19, the Moderna vaccine recipients generated antibody levels of 3,836 units per milliliter, while antibody levels in Pfizer-BioNTech vaccine recipients were 1,444 units per milliliter.

Some 688 volunt…

Overcoming vaccine delivery device design’s top challenges

[Photo by Eugene Chystiakov]

Vaccine delivery has long been a hot topic and only got hotter in the ongoing push to vaccinate against COVID-19 around the world.

Most would probably associate vaccines with the standard “jab” injection with a syringe. Over the past year and more, companies have touted ideas for other avenues. Inovio has a “smart” delivery device for a COVID-19 vaccine, while Intravacc is developing a nasal COVID-19 vaccine, plus there are many more in between.

Whether it’s standard delivery devices or the innovative ones various companies are trying to bring to the market, there are difficulties in creating the vessels for the potentially life-saving therapeutics they deliver.

Drug Delivery Business News spoke with Scott Thielman — chief technology officer at Product Creation Studio, a company that offers insights to deliver designs for a range of entities, including medical device comp…

Mutated COVID-19 variant C.1.2 elicits concern

[Photo by Fusion Medical Animation on Unsplash]

As even countries with substantial vaccination rates such as the U.S., U.K. and Israel continue to fight the Delta variant, a new threat appears to have emerged in South Africa.

First spotted in South Africa, the C.1.2 variant is potentially more infectious and resistant to antibodies than Delta. Scientists continue to study the variant’s potential to infect the vaccinated and unvaccinated.

Scientists first spotted C.1.2 in Mpumalanga and Gauteng, two provinces in Eastern South Africa.

Outside of South Africa, researchers have identified the variant in other African nations, New Zealand, the U.K. and mainland Europe.

Also troubling is that the C.1.2 variant is mutating at a rate of 41.8 mutations annually — 1.7 times the rate of other variants of concern, according to a preprint study published in MedRxiv.

Another MedRxiv prepri…

AstraZeneca mandates COVID-19 vaccination for U.S. employees

AstraZeneca (LON:AZN) will require that its American employees be fully vaccinated if they plan to work in its facilities or visit customers.

Cambridge, U.K.–based AstraZeneca said the plan would also apply to workers at Alexion Pharmaceuticals (Boston, Mass.). AstraZeneca completed its acquisition of Alexion in July.

AstraZeneca employees can seek vaccine exemptions but must obtain a weekly COVID-19 test.

Pfizer (NYSE:PFE), Moderna (NSDQ:MRNA) and Lilly (NYSE:LLY) have announced similar initiatives for U.S. employees.

Outside of the pharmaceutical industry, many notable employees also require vaccine mandates. For example, in finance, Goldman Sachs, Bank of America and JP Morgan Chase have announced such policies.

The federal government has embraced vaccine mandates for its employees.

Tech companies such as Google, Uber and Microsoft are also requiring vaccination of office-based workers.

AstraZeneca plans on shipping up to t…

Third dose of Pfizer COVID-19 vaccine boosts protection in people over 60

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

Israeli researchers report that an additional dose of Pfizer (NYSE:PFE) and BioNTech’s (NISDQ:BNTX) COVID-19 vaccine leads to notable improvements in immunity in people 60 and older.

The protection against infection increased fourfold 10 days after administration of the third dose, according to scientists at the Gertner Institute (Ramat Gan, Israel) and KI Institute (Kfar Malal, Israel). In addition, patients who received a third dose had four to six times greater protection against severe illness and hospitalization.

In people over 60, a third dose was 86% effective in protecting against infection.

The country began distributing booster doses for people over 60 on July 30. In addition, Israel has recently made booster doses available to people 30 and older who had received…

NIH to study third dose of COVID-19 vaccine in people with autoimmune disease

The National Institutes of Health (NIH) has launched a study to gauge the antibody response of a third dose of mRNA COVID-19 vaccine in patients with autoimmune disease. Participants in the study had an insufficient immune response to the primary series of vaccination.

The Phase 2 study will also test the impact of pausing immunosuppressive medication to determine if it improves the antibody response.

The study, titled “COVID‐19 booster vaccine in autoimmune disease non‐responders,” will test an additional dose of vaccines from both Pfizer-BioNTech and Moderna.

The National Institute of Allergy and Infectious Diseases (NIAID), an NIH division, is sponsoring the study.

The study will first focus on people with one of the following autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis.

On Aug. 12, FDA authorized an additional dose of Pfizer-BioNTech and Moderna COVID-19 va…

U.S. could recommend COVID-19 boosters at five months, according to Biden

President Joe Biden [Image courtesy of the White House]

Facing the second-largest COVID-19 wave to date, U.S. regulators are mulling providing boosters three months earlier than initially anticipated.

People who are fully vaccinated would be eligible for a booster dose five months after receiving the second dose, Biden said, noting that the plan was still tentative.

On Aug. 18, U.S. Surgeon General Vivek Murthy said fully vaccinated individuals would be eligible for boosters eight months after administering the second dose of Pfizer or Moderna vaccines.

Earlier this week, WSJ reported that the U.S. was likely to approve boosters at six months.

Regarding the latest potential revision, Biden said U.S. officials were considering advice that “we should start earlier.”

FDA is likely to authorize boosters in September.

Distribution could start on Sept. 20, according to media repor…

Pfizer seeks FDA blessing for COVID-19 vaccine booster

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older.

The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55.

The latest data indicate that a third dose of the Comirnaty vaccine boosts antibody titers and continues to be well tolerated.

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

Pfizer seeks FDA blessing for COVID-19 vaccine booster

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older.

The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55.

The latest data indicate that a third dose of the Comirnaty vaccine boosts antibody titers and continues to be well tolerated.

Trial investigators administered the booster between 4.8 and 8 months after giving the second dose of the COVID-19 vaccine.

The booster resulted in strong protection against the original or wild-type strain of SARS-CoV-2. Specifically, 99.5% of participants had a four-fold increase in neutralizing antibody levels after the third dose.

The most common side effects were similar to those from earlier doses, including injection-site soreness, fatigue, headache, muscle aches and chills.

The comp…