COVID-19 vaccine Archives - Page 16 of 38

Mix-and-match COVID vaccines attract support and backlash

Image courtesy of Pexels

Several countries have embraced the idea of using distinct COVID-19 vaccines for the first and second doses. But a death in Korea is fueling concerns about the strategy, and some public authorities have warned against the practice.

Canada, Korea, Thailand and Germany have authorized the use of a heterologous prime-boost COVID-19 vaccination strategy to manage supply constraints.

A police officer in South Korea, however, has died after receiving first an AstraZeneca vaccine dose followed by a Pfizer dose, according to The Korea Times. Health authorities there will investigate the death of the 52-year-old officer, who passed away three days after receiving his second vaccine dose.

A recent preprint study published in The Lancet suggested that combinations of AstraZeneca and Pfizer vaccines were effective. Data, however, are preliminary.

Germany, Canada and Thailand…

China rebuffs WHO’s plan to continue investigating origins of COVID-19

The possibility that SARS-CoV-2 resulted from a laboratory accident has gained a degree of plausibility among several world leaders.

But China has rejected calls for further investigation into the matter, saying such allegations disregard “common sense,” as Zeng Yixin, vice-minister of the National Health Commission (NHC), said at a press briefing.

White House press secretary Jen Psaki criticized China’s stance, adding in a press briefing that “their position is irresponsible and, frankly, dangerous.”

China has also entertained a theory that Fort Detrick, an Army base in Maryland, is the source of the pandemic.

While the Fort Detrick lab researches infectious viruses, there is no evidence it is the outbreak’s source.

After initially discounting the possibility of the lab-leak scenario, the WHO has recommended further studies in China. Recently, the organization sought to audit laboratories and markets in Wuhan.

The investigation into…

Israel recommends third COVID-19 vaccine dose for the immunocompromised

Photo by cottonbro from Pexels

Israel is following a similar path to the U.K. in its plans to administer a third dose of COVID-19 vaccine to a subset of patients.

U.K. officials recently announced their initiative to provide a booster to high-risk patients, but those plans are preliminary.

Both Israel and U.K. have concluded that fully vaccinated individuals are unlikely to require a booster dose later this year.

The Israeli government, however, is taking more definitive steps in issuing guidance for people who are immunocompromised to receive a third dose of the vaccine from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX). Some medical centers have already begun administering boosters to those who are severely immunocompromised including cancer patients and recipients of organ transplants. While the country is considering providing a third dose for those 60 and older, it hasn’t yet reached a d…

FDA links J&J vaccine to rare cases of Guillain–Barré

The Food and Drug Administration still believes the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, but has concluded that the vaccine is associated with rare cases of Guillain–Barré syndrome. A warning is forthcoming, according to media reports.

Researchers have also linked prior vaccines, including a swine flu vaccine introduced in the 1970s, with the syndrome, which destroys nerves and can cause paralysis and sometimes death. Most frequently, however, the syndrome predominantly affects the lower extremities before ascending to spread muscle weakness. Many people with the condition, however, recover.

Federal officials have concluded that recipients of the Johnson & Johnson COVID-19 vaccine are more likely to contract Guillain–Barré than the background population. A statement from Johnson & Johnson concluded that “the rate of reported cases exceeds the background rate by a small degree.”

FDA stopped short of e…

Why Bioclinica tapped AI in immunotherapy trials early in the pandemic

An AI-based system proved its mettle in screening patients in immunotherapy trials, according to Dan Gebow, chief innovation officer at Bioclinica.

Early in the COVID-19 pandemic, developers of cancer immunotherapies worried that the novel coronavirus would interfere with their clinical trial results.

In previous years, the scientific community established that immunotherapy can rarely cause interstitial lung disease (ILD). An umbrella term covering several conditions such as pulmonary fibrosis that lead to scarring of the lungs, ILD also arises in some patients with COVID-19.

The fact that ILD can arise from COVID-19 and cancer immunotherapies complicated oncology clinical trials, recalled Gebow at Bioclinica, which provides clinical trial adjudication products and services. “Patients in immunotherapy clinical trials were showing up at the emergency room with some type of lung infection,” Gebow said. “You can imagine if you’re the pharmaceutical company…

IMF approves $650B to help countries pay for COVID-19 vaccines

The executive board of the International Monetary Fund (IMF) today approved a $650 billion allocation for COVID-19 vaccines.

IMF managing director Kristalina Georgieva issued a statement today confirming that the executive board concurred in her proposal for a new general Special Drawing Rights (SDR) allocation of $650 billion — the largest allocation in the IMF’s history — to address long-term needs for what she called “the worst crisis since the Great Depression.”

According to the statement, Georgieva will present the SDR allocation proposal to the IMF’s board of governors for their consideration and approval, which, if obtained, would lead to the expectation that the allocation is completed by the end of August.

“This is a shot in the arm for the world,” Georgieva said. “The SDR allocation will boost the liquidity and reserves of all our member countries, build confidence, and foster the resilience and stabili…

Pfizer to ask FDA to authorize booster dose of its COVID-19 vaccine

Pfizer (NYSE:PFE) has said that the efficacy of its vaccine wanes after six months in the presence of contagious variants such as Delta. The company and its German partner plan on using that justification to ask FDA to extend their EUA for their COVID-19 vaccine to cover a booster dose of their mRNA vaccine.

Reuters quoted Pfizer Chief Scientific Officer Mikael Dolsten as saying that a recent uptick in COVID-19 cases in Israel is evidence that the vaccine offers less protection against the Delta variant — especially in those vaccinated six months ago or earlier.

After six months, “there likely is the risk of reinfection as antibodies, as predicted, wane,” Dolsten said.

Israel’s Health Ministry shared data on July 5 that indicated that the Pfizer-BioNTech vaccine remained effective at preventing serious COVID-19 infections, but that it was less effective overall against the Delta variant.

Early Pfizer experiments show that a third dose of BNT…

Several companies could vy for next-gen COVID-19 vaccine market share

[Photo by Daniel Schludi on Unsplash]

A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market.

That could change in the long run, however, as a growing number of companies develop next generation mRNA COVID-19 vaccines, which promise to be more effective and less likely to cause side effects than their predecessors.

While mRNA COVID-19 vaccines are among the most effective vaccines against the novel coronavirus, researchers have linked their use to rare side effects such as myocarditis.

Future mRNA may be better tolerated. mRNA itself promotes an immune response future mRNA vaccines could optimize reactogenicity through refining the dose or structure of the single-stranded RNA molecule.

Such next-gen vaccines will also likel…

President Biden unveils initiative to boost COVID-19 vaccination numbers

President Joe Biden poses for his official portrait Wednesday, March 3, 2021, in the Library of the White House. (Official White House Photo by Adam Schultz)

With new cases of COVID-19 increasing 14% in the past two weeks, President Biden is aiming to convince unvaccinated Americans to get their first dose of the vaccine.

CDC data show that the highly transmissible Delta variant now dominates the U.S., driving close to 52% of COVID-19 cases in the U.S. from June 19 to July 13, according to CDC. Meanwhile, the Alpha variant that first emerged in the U.K. caused 29% of U.S. COVID-19 infections.

“More than 182 million Americans have received at least one shot, including nearly 90% of seniors and 70% of adults over the age of 27,” Biden said in remarks yesterday about the COVID-19 response and the vaccination program.

The U.S. is on the cusp of having 160 million fully vaccinated Americ…

APC debuts ‘medicine accelerator’ in collaboration with Enterprise Ireland

The Dublin-based pharmaceutical R&D firm APC Ltd has launched a ‘Global Centre of Excellence for Vaccine and Advanced Therapeutic Research and Manufacturing.’

The result of a €25 million investment, the new facility will staff 120 new employees.

The facility will have the capacity to produce hundreds of millions of doses of vaccines (including for COVID-19) and other therapeutic products annually.

The new plant will link to supply chains in the U.S. and Europe. Approximately half of APC’s customers are based in the U.S. APC also owns an office in Boston. The trial involves some 400 patients. The protein-based vaccine uses a synthetic version of the SARS-CoV-2 spike protein.

APC is currently partnering with the Australian company Vaxine (Adelaide), which has a Phase 2 trial underway in Iran for a COVID-19 vaccine. Vaxine is a spin-off of Australia’s National Health Sciences Center.

APC’s ‘Global Centre of Excellence for Advanced Therapeu…

Emergent BioSolutions facing a shareholder lawsuits

The Baltimore-based company Emergent BioSolutions (NYSE:EBS) is the subject of at least four lawsuits asking for refunds and pushing for change in the company’s executive ranks. Some of the lawsuits targeting Emergent accuse the company of securities fraud and insider trading.

Emergent has denied the allegations. “Our executives strictly follow the law and our own internal policies to prevent any improper securities trading,” Emergent spokesperson Matt Hartwig told The New York Times.

In any event, the past year has not been kind to Emergent BioSolutions, the multinational biopharma company focused on vaccines and antibody therapeutics.

After initially scoring the support of Johnson & Johnson (NYSE:JNJ) and AstraZeneca (LON:AZN) to manufacture their respective COVID-19 vaccines, the company saw its stock leap to a peak value of $133.42 on Aug. 14, 2020.

In afternoon trading today, its stock’s value was $61.87.

The drop in valuation resu…

Pfizer to seek to expand COVID-19 vaccine EUA to children aged 5 to 11

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the U.S. emergency use authorization (EUA) for their COVID-19 vaccine to include children aged five to 11.

The companies plan on filing paperwork for the expanded EUA over the coming months. “We are planning for emergency use authorization submission for [children aged five to 11] in September or October of this year, and the [two-to-five-year-old] group to follow soon thereafter,” Alejandra Gurtman, MD, Pfizer’s vice president of vaccine clinical research and development, said during a virtual symposium.

FDA has already authorized the vaccine for people 12 and older.

Pfizer’s Phase 1/2/3 study testing vaccine safety and efficacy in children has enrolled approximately 4,500 participants aged six months to 11 years old. Some 90 clinical trial sites in the U.S., Poland, Spain and Finland are taking part in the trial.

The Phase 1/2/3 trial involving children aged six months to 1…