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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…

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…

Could the controversial drug ivermectin save lives?

[Photo by Fusion Medical Animation on Unsplash]

The antiparasitic drug ivermectin holds promise as a COVID-19 treatment, according to a new study published in the American Journal of Therapeutics. The study authors conclude that ivermectin could reduce the risk of COVID-19-related death with moderate-certainty evidence. “Using ivermectin early in the clinical course may reduce numbers progressing to severe disease,” they conclude, adding that the drug is “likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

The meta-analysis analyzed databases up to April 2021, drawing from 24 randomized controlled trials with 3,406 patients.

Another study published in Lancet found a concentration-dependent antiviral activity of oral high-dose ivermectin in a trial involving 45 patients.

Many experts, however, have voiced skepticism regarding the use of ivermectin as a COVID-19 treatment.…

Moderna vaccine highly effective two weeks after first dose

A study published in JAMA involving healthcare workers found that the first dose of Moderna’s (NSDQ:MRNA) COVID-19 vaccine was highly effective at reducing the risk of COVID-19 infections.

In the study, participants received two doses of the vaccine at the recommended 28-day interval. Clinical effectiveness reached 95% for days 15 through 42 of the study. But constraining the window to days 15 to 28 resulted in similar results.

The findings suggest that the vaccine can rapidly reduce the incidence of vaccine-sensitive SARS-CoV-2 infection in healthcare workers.

Even eight days after administration of the first dose, the vaccine yielded greater than 70% efficacy.

The study authors concluded that their findings were in line with aggregated data for the Pfizer-BioNTech BNT162b2 and Moderna’s mRNA-1273 vaccines.

The 42-day study began on Dec. 22, 2020. It involved 4,028 participants.

A number of healthcare workers have made headlines rec…

Recent study finds Pfizer vaccine effective against Delta variant

The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) leads to a strong neutralizing antibody response to the B.1.617 variant, according to a recent study published in Nature.

The study focused on the B.1.617.2 subtype of the virus. Two others exist, known as B.1.617.1 and B.1.617.3.

The study did acknowledge that the antibody response to the B.1.617 was less robust than it was for the USA-WA1/2020 strain.

The study concluded that mass immunization with the BNT162b2 vaccine should be a central strategy to end the pandemic.

Researchers first identified the B.1.617 variant in India. The so-called Delta variant now accounts for approximately 6% of COVID-19 infections in the U.S. It is also the dominant variant in the U.K. Various subtypes of B.1.617 exist.

The predominance of B.1.617 in the U.K. underscores its potential to outcompete against B.1.1.7, the so-called “U.K. strain” that became dominant in …

FDA authorizes lower dose of REGEN-COV COVID-19 antibody cocktail

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200 mg of Imdevimab.

The initial EUA for REGEN-COV did not include the option for a subcutaneous dose of the antibody cocktail. The option to make the product available via injection makes it easier for doctors or nurses to administer. The use of SARS-CoV-2 monoclonal antibodies has lagged behind vaccines, with only a fraction of eligible patients receiving such antibodies in the past year.

FDA came to its decision after reviewing data from a pivotal Phase 3 study that showed that the drug reduced the risk of hospitalization or death by 70%. The efficacy of the reduced dose is similar to the 2,400 mg dose.

REGEN-COV appears to be …

COVID-19 lab-leak theory re-emerges as U.S. intelligence report surfaces

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

A previously undisclosed U.S. intelligence report revealed that three scientists from China’s Wuhan Institute of Virology became sick enough in November 2019 to seek hospital care, according to the Wall Street Journal.

The illnesses were consistent with both COVID-19 and common seasonal illnesses, but the report fuels speculation that the scientists at the Wuhan lab were among the first to contract the SARS-CoV-2 virus.

The disclosures have heightened calls for an independent probe into the origin of the pandemic because the Wuhan Institute of Virology has researched coronaviruses. The time frame of the workers’ hospital visits coincided with the beginni…

FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020.

The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic COVID-19. The vaccine also had favorable reactogenicity in 12- to 15-year-olds in the study involving 2,260 participants.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” wrote Acting FDA Commissioner Janet Woodcock, MD, in prepared remarks. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

An advisory committee of the Centers for Disease Control and Pr…

A quick history of the tech behind J&J, AstraZeneca’s COVID-19 vaccines

Transmission electron micrograph of two Adenovirus particles. Image courtesy of Wikipedia.

After regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), some regulatory authorities wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events.

Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s in early experiments with the platform. But the safety of the platform has improved as genetic engineering has advanced.

The history of using viruses as vectors dates back to the mid-1970s when scientists Dr. J. Michael Bishop and Dr. Harold Varmus demonstrated that gamma-retroviruses could acquire cellular genes.

Researchers began creating adenoviral vectors in the 1980s, testing replication-de…

Annual COVID-19 vaccines likely, according to Pfizer CEO

The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today.

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview.

While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based on an mRNA platform.

Adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson are currently in limited use, given concerns that they could cause rare but serious blood clotting problems.

The mRNA vaccines from Moderna and Pfizer/BioNTech also have a head start, and U.S. officials expect 600 million doses of the vaccines to be delivered by the end of July.

It will be “a stretch for adenoviral-vector vaccines to have any material uptake,” in the U.S., said Navin Jacob, a senior equity research analyst at UBS. “And you can’t really give boosters with the adenoviral-vector vaccin…

Lilly to prioritize selling antibody cocktail for COVID-19

Eli Lilly (NYSE:LLY) announced that it had amended purchase agreements with the U.S. government to prioritize using two monoclonal antibodies — bamlanivimab and etesevimab — in tandem.

In March, the U.S. government announced that it would stop using bamlanivimab alone, given its reduced efficacy against some SARS-CoV-2 variants.

But pairing anti-SARS-CoV-2 monoclonal antibodies together can offer more robust protection against variants. Using two of the monoclonal antibodies together is more protective than administering either alone.

The COVID-19 Treatment Guidelines Panel of the National Institutes of Health has recommended pairing Lilly’s bamlanivimab with etesevimab or Regeneron’s (NSDQ:REGN) cocktail combining casirivimab and imdevimab.

Bamlanivimab and etesevimab image courtesy of Eli Lilly.

Regeneron’s REGEN-COV drug is an antibody cocktail combining casirivimab and imdevima…

Pfizer asks FDA to authorize its COVID-19 vaccine for younger teens

Pfizer (NYSE:PFE) and its German partner BioNTech (NSDQ:BNTX) have asked FDA to extend the authorization of their COVID-19 vaccine to the ages of 12 to 15.

FDA authorized the vaccine for people 16 and older on Dec. 11, 2020.

The agency will likely extend its prior authorization to younger adolescents “if the data submitted support it,” according to Dr. Arnold Monto, acting chair of the Vaccines and Related Biological Products Advisory Committee meetings related to the Pfizer-BioNTech.

Pfizer plans to seek permission from other regulatory agencies to administer the vaccine to children 12 and over in the coming weeks.

The company currently has a Phase 3 trial underway involving 2,260 adolescents 12 to 15. The vaccine was 100% effective in that study, besting the results of a separate trial involving volunteers aged 16 to 25.

All 50 states plan to open up vaccine eligibility to those over 16 starting April 19.

Pfizer and BioNTech a…