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Pfizer, CDC differ on need for vaccine booster shots; FDA warning letter to Lupin reveals repeat violations
This week, Phispers brings you news on Intellia’s gene-editing technology that showed improvements in patients with inherited liver disorder. Pfizer Korea halted the circulation of its anti-nicotine therapy due to nitrosamine impurities. Walmart launched its own brand of low-priced analog insulin, in collaboration with Novo Nordisk, known as ReliOn NovoLog. And the FDA issued a warning letter to Lupin’s subsidiary in US over GMP violations.
In Covid news, while drugmakers Moderna and Pfizer are stressing that the world will soon need booster shots to maintain high levels of immunity, CDC scientists have said there isn’t enough data to support recommending Covid-19 booster shots to the general population, but that the more-vulnerable groups may need an extra dose. The FDA has granted emergency use authorization to Roche’s arthritis drug to treat hospitalized Covid patients. However, the distribution of Eli Lilly’s antibody combo in the US has been halted since it does not provide protection against all variants. Pfizer and Moderna said their vaccines are effective against the Delta variant, first identified in India. And Sanofi said it will invest US$ 476 million a year in a dedicated vaccines mRNA Centre of Excellence.
Vaccine updates: CDC says not enough data to recommend booster shots; Pfizer differs
Last week, a group of Centers for Disease Control and Prevention (CDC) scientists said there isn’t enough data, at present, to support recommending Covid-19 booster shots to the general population but that more-vulnerable groups, such as the elderly or transplant recipients, may need an extra dose.
However, the Covid-19 working group of the CDC’s Advisory Committee on Immunization Practices didn’t rule out the possibility that the general population eventually may need booster shots if immunity from the vaccines wanes or a variant reduces the effectiveness of current shots.
A recent study by researchers at Johns Hopkins University published in the Annals of Internal Medicine showed that booster shots may be beneficial for people with weakened immune systems.
Even the World Health Organization (WHO) has said that people most vulnerable to Covid-19, such as the elderly, will need to get an annual vaccine booster to be protected against variants. Britain plans to start its booster campaign for the elderly and most vulnerable from September.
Moderna and Pfizer have been vocal in their view that the world will soon need booster shots to maintain high levels of immunity. According to Pfizer, those inoculated with the Pfizer-BioNTech vaccine shot will need a booster dose as early as this fall.
Pfizer is working on two different booster-shot strategies — a third 30 mg dose of its current vaccine and an updated jab that targets the Beta variant, first identified in South Africa. The company is expecting immunogenicity data for both studies as early as July.
Pfizer, Moderna say their jabs are effective against Delta variant: The Delta variant, which was first identified in India, is becoming the globally dominant variant of the coronavirus, according to the WHO.
A study by researchers from the University of Texas together with Pfizer and BioNTech, published this month by Nature journal, found that antibodies elicited by the vaccine were still able to neutralize all tested variants, including Delta, though at a reduced strength. A Pfizer official in Israel also said the vaccine is highly effective against the Delta variant.
Similarly, Moderna’s vaccine showed promise against the Delta variant, with a modest decrease in response compared to the original strain, the company said. The study was conducted on blood serum from eight participants obtained one week after they received the second dose of the vaccine, mRNA-1273. The vaccine provoked an antibody response against all variants tested, according to Moderna. The vaccine was far more effective in producing antibodies against the Delta variant than against the Beta variant, the data showed.
Boosters maybe needed after J&J shot, say experts: Infectious disease experts are weighing the need for booster shots of the Pfizer or Moderna mRNA-based vaccines for Americans who received Johnson & Johnson’s single-dose vaccine due to the increasing prevalence of the more contagious Delta coronavirus variant. Canada and some European countries are already allowing people to get two different Covid-19 shots. The debate centers on concerns over how protective the J&J shot is against the Delta variant first detected in India.
Meanwhile, early results from a British vaccine study suggest that mixing different brands of vaccines can provide strong protection against Covid-19. In the trial, volunteers produced high levels of antibodies and immune cells after getting one dose of the Pfizer-BioNTech vaccine and one dose of the AstraZeneca-Oxford shot.
Sanofi’s mRNA vaccine center: French drugmaker Sanofi plans to invest US$ 476 million (€400 million) a year in a dedicated vaccines mRNA Center of Excellence. The commitment is intended to establish Sanofi as a front-runner in the race to develop mRNA vaccines against a wide range of infectious diseases. The goal is to have at least six candidates in the clinic by 2025 and compete with other companies to disrupt the vaccine industry.
With the Covid-19 pandemic validating mRNA vaccines in the prevention of infectious diseases, several companies (including Moderna and Pfizer) are now looking to expand use of the technology beyond the coronavirus. Sanofi, which has access to mRNA technology through its partnership with Translate Bio, took an early lead over its rivals in flu last week by starting a phase 1 clinical trial.
FDA issues warning letter to Lupin’s subsidiary in US over GMP violations
Generic drugmaker Lupin, Inc received a warning letter from the US Food and Drug Administration (FDA) over good manufacturing practice (GMP) issues at a facility of Novel Laboratories, Inc — one of its US-based subsidiaries.
In the warning letter, dated June 11, the agency cited GMP violations at Novel Laboratories’ Somerset, New Jersey, facility. The FDA said the issues cited in the warning letter include repeat violations cited in recent warning letters concerning three Lupin facilities in India.
The warning letter follows a nearly two-months-long inspection that occurred from 10 September to 5 November 2020.
The first violation concerns adherence to equipment cleaning and maintenance procedures. The investigator observed that “cleaning and preventative procedures … did not include cleaning instructions for these areas or a regular inspection of the air ducts.”
The next violation concerns Novel Laboratories’ written procedures for production and process change control. “You failed to adequately validate the manufacturing processes for temazepam 15 mg and 30 mg capsules before the transfer of product manufacturing to a new building,” the FDA wrote. The agency notes that several batches manufactured with these changes had out-of-specification (OOS) test results. Lastly, the FDA admonished the firm for failing to establish and follow adequate written responsibilities and procedures for its quality control unit.
Intellia’s gene-editing treatment shows promise in patients with inherited liver disorder
Last year, two scientists — Emmanuelle Charpentier and Jennifer Doudna — had won the Nobel Prize for discovering one of gene technology’s sharpest tools: the CRISPR/Cas9 genetic scissors. Using these, researchers can change the DNA of animals, plants and microorganisms with extremely high precision.
Last week, the world got news from a clinical trial of genome editing inside the human body. And it was good news.
At a meeting of neurologists held last week, researchers said the first patients to get Intellia Therapeutics’ gene-editing treatment showed improvements in their inherited liver disorder. And there were no apparent safety problems.
The experimental treatment repairs an errant gene that causes a buildup of a misfolded protein — ATTR — in the nerves and heart that is often fatal. Interim data on the first six patients in the Phase 1 trial showed that a single dose of the treatment reduced blood levels of the harmful ATTR protein by an average of 87 percent.
With first-ever in-vivo clinical data supporting the safety and efficacy of CRISPR genome editing, Intellia now has “a more de-risked platform with this capability,” Jefferies analysts said.
The encouraging data is also good news for Regeneron Pharmaceuticals, Intellia’s partner in developing the treatment. The two drugmakers will split profits if the treatment reaches the market. But this could be less welcome news for Pfizer and Alnylam Pharmaceuticals, two companies with fast-growing new drugs for treating ATTR amyloidosis. Pfizer’s Vyndaqel and Vyndamax don’t stop patients’ livers from producing the misfolded ATTR proteins, but the drugs render the proteins less harmful.
Pfizer Korea halts circulation of anti-nicotine therapy due to nitrosamine impurities
Pfizer Korea has stopped the distribution of its anti-nicotine therapy — Champix — to dispel concerns over the presence of nitrosamine impurities, a possible carcinogen, in the treatment. The company said it is a precautionary measure taken due to the possibility that impurities may have arisen in the manufacturing process of the finished drug.
The supply stop comes after the Korean government said the drug had been recalled by the Canadian authorities due to the presence of N-nitrosovarenicline above the acceptable concentration level. Pfizer Korea said it receives the supply of Champix from Germany.
“Pfizer Korea puts patient safety and pharmaceutical quality as top priorities,” a company spokesperson told Korea Biomedical Review. “We want to ensure patient access to reliable treatments that have proven its safety.”
FDA grants EUA to repurposed Roche drug against severe Covid-19
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Roche’s arthritis drug — Actemra — to treat hospitalized Covid-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.
Last week, the FDA said it had issued emergency use authorization (EUA) for Actemra to treat adults and pediatric patients hospitalized with Covid-19. The drug can be used to treat patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation, the FDA said, adding that studies showed Actemra helped reduce risk of death and speed up recovery.
Lilly’s antibody combo halted in US: The US is pausing the national distribution of Eli Lilly’s Covid-19 antibody combo of bamlanivimab and etesevimab. Lilly was the first company to score an FDA emergency nod for a Covid-19 antibody drug.
The Centers for Disease Control and Prevention (CDC) has warned that the SARS-COV-2 Gamma variant, first identified in Brazil, and the Beta variant, which originally surfaced in South Africa, now make up for more than 11 percent of the sequenced US coronavirus cases. And that number is going up, the CDC said.
In vitro assays have shown that bamlanivimab and etesevimab together “are not active against either” variant.
In lieu of Lilly’s antibody combo, the US recommends healthcare providers switch to other authorized monoclonal antibody drugs, such as Regeneron’s cocktail — Regen-Cov — and GlaxoSmithKline and Vir Biotechnology’s sotrovimab.
Walmart launches its own brand of low-priced analog insulin, targets 3 million diabetic customers
This week, the world’s largest retailer — Walmart — began selling a lower-price version of analog insulin, a diabetes drug. Walmart developed the less expensive version of analog insulin with Novo Nordisk, known as ReliOn NovoLog.
The retail behemoth will sell ReliOn NovoLog at its US pharmacies to those with a prescription. The medicine will cost between 58 to 75 percent lesser than the current cash price of branded insulin products for uninsured patients, Walmart said.
More than 3 million Walmart customers are diabetic, and the retailer already offers human insulin to them for about US$ 25. But that type is inferior to analog insulin, a man-made variety that’s designed to better mimic the body’s own blood-sugar production and regulation.
Meanwhile, David Ricks, the CEO of Eli Lilly, a leading manufacturer of insulin, said he welcomes new competition from Walmart.
“Any efforts to smash through that and deliver better value to patients, I’m for,” Ricks said in an interview. Eli Lilly has faced pushback for its high insulin prices by American politicians. Eli Lilly’s generic version costs nearly twice that of Walmart’s analog insulin (at US$ 137.35 per vial).
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