Target $12
Wednesday, April 21, 2021
EU ‘will not take up’ extra 300m Covid-19 shots in AstraZeneca, J&J contracts
The EU won’t take up an extra 300 million doses of AstraZeneca and Johnson & Johnson Covid-19 vaccines that it has secured as options under existing contracts, a senior EU official has told Reuters.
The decision is the latest sign Brussels is looking to distance itself from AstraZeneca amid simmering tensions after the drugmaker slashed its delivery targets for vaccines to the bloc due to production problems.
It is also further evidence the bloc is sidelining vaccines that have been linked with a very rare but potentially fatal side effect, and is confident other current suppliers – led by Pfizer/BioNTech – will deliver enough doses to inoculate at least 70 per cent of EU adults by the end of the summer.
Recently, the EU has sought to buy more shots from Pfizer and its partner BioNTech, stepping up its bets on the messenger RNA (mRNA) technology they use in their jab, as opposed to the viral vector technology used by AstraZeneca and Johnson & Johnson (J&J).
The 27-nation bloc has a contract for a total of 400 million doses with J&J, of which only 200 million have already been ordered, and a separate contract with AstraZeneca for 400 million shots in total, of which only 300 million have been bought.
“There is no need to exercise the options” for the extra doses, the senior EU official, who is directly involved in talks with vaccine-makers, said.
EU governments are under pressure to accelerate their Covid-19 vaccination programmes, which have lagged behind those in Britain and the US due to supply delays and safety concerns, in order to help tame a third wave of infections on the continent.
A spokesman for the European Commission, which co-ordinates talks with vaccine-makers, said options can be exercised at any time, but declined further comment.
Booster shots
The senior EU official, who asked not to be named because the matter is confidential, said discussions were ongoing about further supplies for booster shots and to address coronavirus variants, and it was premature to rule AstraZeneca and J&J out of future contracts.
But the technology on which their shots are based is less appealing than other vaccine platforms, the official said. Last week, Italian newspaper La Stampa reported that the EU would not renew contracts with the two companies when the contracts expire.
Both the AstraZeneca and J&J Covid-19 vaccines have been linked to very rare cases of blood clots, leading to some temporary suspensions in the use of the former, although the EU drugs regulator has concluded the benefits of both vaccines outweigh the risks.
Both companies have also had production problems, with AstraZeneca in particular slashing its EU supply targets by two-thirds to 100 million doses by the end of June, sparking fury in Brussels.
The EU official said AstraZeneca’s supply problems had convinced EU negotiators not to seek the optional extra doses from the company. Under the contract, that option should have been exercised by early March, although the EU could have still tried to order more doses after then.
A spokesman for AstraZeneca declined to comment.
The EU official added that, in the case of J&J, initial safety concerns about viral vector technology had pushed negotiators not to seek the optional doses and might also prevent talks for a new contract.
A spokeswoman for J&J declined to comment.
Widely criticised
The EU’s existing Covid-19 vaccine contracts have been widely criticised for being too lenient with companies because they set quarterly rather than monthly delivery targets, although other countries have done the same.
Last week, the European Commission said it was starting talks with Pfizer and BioNTech to buy up to 1.8 billion Covid-19 vaccine doses for the coming years under a new contract with monthly targets, as it prepares for the possible spread of new virus variants and potential waning protection from initial shots.
The EU source said the new contract with Pfizer and BioNTech was expected to meet a large share of the EU’s demand in 2022 and 2023.
The bloc, with a population of nearly 450 million, has already ordered 600 million Pfizer/BioNTech vaccines for this year. It has also bought 310 million doses from Moderna to be delivered this year, and has an option to buy another 150 million doses from the vaccine-maker next year. Moderna also uses mRNA technology.
The EU also has contracts with CureVac and Sanofi, but neither of them has completed clinical trials for their vaccines.
Novo Nordisk to initiate phase 3a development in obesity with oral semaglutide
Novo Nordisk today announced the decision to enter phase 3a development in obesity with oral semaglutide 50 mg. The decision follows the completion of the STEP phase 3a clinical programme with once-weekly subcutaneous (sc) semaglutide 2.4 mg.
Novo Nordisk intends to initiate a pivotal phase 3a programme with approximately 1,000 people with obesity or overweight with comorbidities. The global 68-week trial is planned for initiation in the second half of 2021 and will investigate the efficacy and safety of oral semaglutide compared to placebo.
“There is a significant unmet medical need within obesity treatment today. With oral semaglutide we aim to introduce a convenient and effective treatment option for people with obesity and healthcare providers enabling broader use of anti-obesity medication,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk. “As a complement to our injectable anti-obesity medications, oral semaglutide has the potential to help more people living with obesity achieve weight loss goals and improve their health.”
https://finance.yahoo.com/news/novo-nordisk-initiate-phase-3a-135200852.html
FDA Finds Poor Conditions at Contractor's Plant Making J&J Vax
A contract manufacturing plant that is supposed to help make Johnson & Johnson's Covid-19 vaccine didn't keep clean, sanitary conditions and failed to take proper steps to prevent contamination, federal health regulators said Wednesday.
Among the problems identified during the regulators' inspection of the plant: cross-contamination of two different vaccines in production at the plant. Their names were redacted, but people familiar with the matter have said they are the Covid-19 vaccines from J&J and from AstraZeneca PLC.
The U.S. Food and Drug Administration, which inspected the plant owned by contract manufacturer Emergent BioSolutions Inc., said it completed the inspection on Tuesday and would work with Emergent to address the findings from the inspection.
Production of J&J's vaccine at the Emergent plant has been paused, and material already manufactured will undergo additional testing before it is released for potential distribution, the FDA said.
"We will not allow the release of any product until we feel confident that it meets our expectations for quality," said FDA Acting Commissioner Janet Woodcock and Peter Marks, who heads the FDA department overseeing vaccines.
The Emergent plant recently had a contamination-related mishap that ruined a batch of the main ingredient for J&J's Covid-19 vaccine. No doses were distributed from the failed batch, and the FDA hasn't authorized doses using material from the Emergent plant to be distributed.
The mishap led to J&J taking over responsibility for producing its vaccine at the Emergent plant.
Emergent, of Gaithersburg, Md., said it is working with the FDA and J&J to quickly resolve the issues identified.
"While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them," the company said.
J&J, of New Brunswick, N.J., said it will ensure that all of the FDA's inspection findings are addressed promptly and comprehensively. The company said it is trying to secure FDA authorization for making the main ingredient at the Emergent plant as quickly as possible.
The doses of J&J's vaccine that have been distributed in the U.S. contain drug substance manufactured at J&J's own plant in the Netherlands.
The FDA's inspection of the Emergent plant is unrelated to the agency's probe of serious blood-clot conditions seen in a handful of people after they received the J&J Covid-19 vaccine.
Vaccinations with J&J's shot have been paused in the U.S. while health authorities investigate the blood-clotting issue.
FDA inspectors conducted their inspection at Emergent's Baltimore plant from April 12 through April 20.
At the conclusion of the inspection, they issued a Form 483, which is a summary of findings that a plant didn't meet quality standards. The FDA expects drug companies to fix issues identified in a Form 483.
Their 13-page inspection report, which is partially redacted, outlines numerous lapses in meeting quality standards at the plant.
The FDA cited cross-contamination of a batch of one viral vaccine with material used for a second viral vaccine, which the agency said Emergent failed to prevent and properly investigate.
The names of the two vaccines involved are redacted in the report, but people familiar with the matter have said the cross-contamination was between materials used for the Covid-19 vaccines from J&J and from AstraZeneca and its partner the University of Oxford.
The AstraZeneca-Oxford vaccine hasn't been authorized for use in the U.S., while J&J's shot was cleared in late February. Production of the AstraZeneca vaccine at the Emergent plant has been stopped and is being moved elsewhere.
The FDA inspection report said that a worker who dispensed raw materials for one of the vaccines entered separate areas of the plant where the two vaccines were being made. Emergent didn't properly investigate personnel movements around the plant as a potential source of the contamination, the report said.
The report says Emergent didn't maintain the plant "in a clean and sanitary condition." Waste generated during the manufacture of the two vaccines wasn't decontaminated using qualified methods, and the waste was transported through a warehouse in a way that created the potential to contaminate the warehouse, the report said.
FDA inspectors also found peeling paint on the floors and walls, paint flecks on the floor, and rough surfaces that don't allow for adequate cleaning and sanitation.
The FDA inspectors viewed security-camera footage at the plant and spotted several instances of workers failing to prevent cross-contamination. In January and early February, workers threw unsealed bags of special medical waste into a service elevator, and when carrying the bags they came into contact with containers of manufacturing materials, the FDA report said.
Workers also failed to adhere to proper procedures for wearing sterile gowns and other steps meant to avoid contamination, the report said.
Anthem warns of higher non-COVID-19 costs in coming quarters
Anthem Inc on Wednesday warned of higher medical costs in the coming quarters due to a sooner-than-anticipated rebound in demand for non-COVID-19 healthcare services as more Americans get vaccinated.
For much of last year when the pandemic was at its peak, health insurers benefited from lower patient use of elective, non-COVID healthcare services.
"Given a faster rollout of the vaccine, we expect non-COVID utilization to rebound sooner, and we now expect to absorb higher COVID vaccination administration costs during the second quarter," Anthem Chief Financial Officer John Gallina said.
Shares of the company were down about 0.5% at $380.30.
"The expected return of care utilization is somewhat optimistic. We continue to see variable inoculation rates for COVID-19 across specific markets, as well as hesitancy from consumers to return to in-person care," Forrester analyst Arielle Trzcinski said.
Anthem's comments were made during a post-earnings conference call after the company reported quarterly profit that beat estimates and raised its full-year profit outlook.
The raise follows a similar move by larger rival UnitedHealth, which said last week it saw a decline in COVID-19 related expenses during February and March as U.S. vaccination efforts helped ease case burden.
For 2021, Anthem expects adjusted net profit of more than $25.10 per share, up from its previous forecast of over $24.50 per share.
Gallina said the company's forecast assumes a negative impact from the potential for a prolonged fourth wave of COVID-19 and pent-up demand for healthcare services that were delayed by patients throughout the pandemic.
Even though Anthem's outlook assumes COVID-19 related costs of about $600 million, it stuck to its long-term annual target of 12% to 15% growth in adjusted profit.
Excluding items, Anthem earned $7.01 per share in the quarter ended March 31, compared with analysts' average estimate of $6.51.
Op-Ed: Medical Misinfo on Display During Derek Chauvin Trial
Update: Derek Chauvin has been found guilty of murdering George Floyd.
Former police officer Derek Chauvin is accused of killing George Floyd by restraining him in a way that led to his death. The prosecution says that Chauvin's restraint caused Floyd to be unable to breathe, which resulted in a lack of oxygen and death. The defense argues that Floyd's underlying health problems -- primarily coronary artery disease, hypertension, and drug abuse -- led to his death.
Both sides seem to have overlooked an important medical aspect of this case. They are missing the importance of Floyd's initial cardiac rhythm, determined by the paramedics who arrived on the scene. It was pulseless electrical activity (PEA).
What Caused Floyd's PEA?
PEA is characterized by a heart that has normal or near-normal QRS complexes on an electrocardiogram, but has no effective contraction, no effective heartbeat.
There are specific causes of PEA. One is a massive pericardial effusion surrounding the heart that squeezes the heart so tightly that it can't move or contract. But that fluid does not damage the electrical system of the heart, so the electrical system will continue to generate QRS complexes. Another cause is severe blood loss. If very little or no blood gets into the heart then it will not contract, but the electrical system may continue to work, causing PEA. And another cause is severely low oxygen levels. Severely low oxygen levels can cause the heart to not contract in an effective manner, but the electrical system may still function and produce QRS complexes, hence PEA.
A cardiologist who testified in the Chauvin trial said that Floyd was in a PEA rhythm. The emergency department physician who cared for Floyd said the same thing. The forensic pathologist who testified for the defense said the same thing. Hence, there seemed to be agreement that Floyd was in PEA.
The dispute arose over the mechanism of that PEA. The prosecution said it was caused by Chauvin restraining Floyd in such a way that he could not breathe. This led to falling oxygen levels, which led to PEA. The doctor for the defense said that Floyd had 90% blockage of his right coronary artery and that a branch from the right coronary artery feeds the sinus node. He said the stress of the situation along with Floyd's other health problems and the blocked right coronary led to lack of blood flow to the sinus node, which triggered a fatal arrhythmia. It was this fatal arrhythmia that caused his heart to stop and his oxygen levels to fall.
There are several problems with the scenario put forward by the defense. If the primary problem was an electrical one, which began with damage to the sinus node, then why would Floyd go into PEA? If his electrical system was so badly damaged that it caused a cardiac rhythm, such as ventricular fibrillation (Vfib), that caused his heart to stop, then how could it have recovered to the point that it would make normal or near normal QRS complexes, which are seen in PEA? With PEA, the electrical system of the heart is not as severely damaged. Rather, the heart is not beating for reasons other than a primary electrical problem. It would be very odd for a patient to go from Vfib to PEA, unless there were medical interventions such as CPR, medications, and/or defibrillation via shocks to the heart. Floyd had none of these, not even CPR, before the paramedics arrived. Therefore, it is highly unlikely that Floyd went from a Vfib arrest that was not addressed for at least 10 minutes to a PEA rhythm -- such a situation may even be unheard of. I was surprised that this was not brought up during the trial. One explanation might be because the PEA diagnosis was not definitive, yet several authorities claimed that was the case.
Something else that was not brought up was that the sinus node is not supplied by the right coronary artery 100% of the time. About 40% of the time it comes off the circumflex artery. Also, when it does come off the right coronary, it comes off at a proximal point. If it came off above the blockage, that would be relevant. But, surprisingly, this was not discussed or investigated.
Overlooking Medical Fact Missteps
I'm also surprised at some things that were brought up. The doctor for the defense said that adrenaline release probably contributed to Floyd's death. He said that adrenaline (also known as epinephrine) is a vasoconstrictor, implying that it would cause coronary vasoconstriction and thereby put Floyd's heart in further danger of a fatal arrhythmia. However, adrenaline is not a vasoconstrictor of the coronary arteries. This has been shown in many studies, such as one in the American Heart Association journal Circulation Research. A quote from this study: "epinephrine resulted in a 37% increase in coronary blood flow." Hence, the doctor for the defense did not know this basic medical information. Or, he did not tell the truth as part of a strategy. No one pointed out this mistake.
This doctor made a similar mistake about carbon monoxide. He saw a picture of Floyd lying on the ground near an exhaust pipe. This led him to speculate that Floyd may have inhaled fumes, resulting in high levels of carbon monoxide in his blood. However, he did not know whether the car was running. Also, the carboxyhemoglobin level in Floyd was measured -- and determined not elevated. This measurement was discovered after this doctor had left, so when the prosecution tried to bring it up, the defense objected. The judge agreed with the defense and said that if the prosecution referred to this result there would be a mistrial. To approach the carboxyhemoglobin level with a threat of a mistrial speaks to fundamental problems with our legal system: it is more interested in protocol and its rules than the truth. Also, it lacks a scientific approach.
To approach this scientifically and medically would be to formulate a hypothesis such as: If George Floyd had a high level of carbon monoxide in his body, then this, in part, led to his death. A measured carboxyhemoglobin measurement would support or refute that hypothesis. There was such a measurement. Therefore, a scientific -- and reasonable -- approach would be to simply look at the level. But instead, the court said the jury could not see that level. It was off limits. This kind of stuff is an inherent part of our legal system. We would be better off to take a more scientific approach.
Focus on the Truth
The testimony of the doctor for the defense demonstrates problems with both our legal system and the medical profession. He presented medical information that was false, yet he was never challenged in the trial. His testimony also demonstrates problems with the profession of medicine. As a professor of pathology and residency director during his career, the doctor was very involved in the teaching of residents. What did he teach them? Did he teach them how to twist the truth for the sake of gain? Or, did he just teach them incorrect information, such as what he said about adrenaline, because he didn't know any better?
An important lesson from the Chauvin trial is this: we need to reform both our legal and medical systems. We need to place more emphasis on truth and knowledge, and less emphasis on twisting the truth.
W. Robert Graham, MD, completed medical school and residency at UTHSC-Dallas (Parkland Hospital) and served as chief resident. Graham received an NIH fellowship at the Salk Institute for oncogene research in 1985. He was a professor of medicine at Baylor College of Medicine from 1998 to 2016. In retirement, he enjoys writing and ranching.
https://www.medpagetoday.com/publichealthpolicy/generalprofessionalissues/92164
Texas A&M researchers spot new coronavirus variant
Texas A&M researchers have found a new coronavirus variant, called BV-1 for the surrounding Brazos Valley area, though there are still many unknowns, according to a university release posted Monday.
The variant was detected in a saliva sample from just one student who had "mild cold-like" symptoms through the school's testing program, the university said, but given genetic similarities in the strain to other variants that have shown to reduce neutralization power from antibody treatments, the researchers wanted to share the news globally. The variant is "related" to the U.K. B.1.1.7 variant, which according to the Centers for Disease Control and Prevention (CDC) is now the "most common lineage circulating in the U.S."
"We do not at present know the full significance of this variant, but it has a combination of mutations similar to other internationally notifiable variants of concern," said Ben Neuman, chief virologist at the Texas A&M University Global Health Research Complex, in the university release. "This variant combines genetic markers separately associated with rapid spread, severe disease and high resistance to neutralizing antibodies."
The student’s sample was positive on March 5, and a second sample on March 25 came back positive again, which researchers suggest indicates a longer-lasting infection among young adults. A third sample on April 9 was negative, and the student's symptoms had resolved.
The student lives off-campus but is involved in on-campus organizations, according to the university. Neuman said Texas A&M will closely monitor for cases "given its potentially concerning genetic make-up" by sequencing samples from asymptomatic students too, to spot variants before they progress to severe illness.
"Sequencing helps to provide an early warning system for new variants," Neuman said in the release. "Though we may not yet understand the full significance of BV-1, the variant highlights an ongoing need for rigorous surveillance and genomic testing, including among young adults with no symptoms or only mild symptoms."
The researchers submitted their findings to the CDC.
https://www.foxnews.com/health/texas-am-researchers-spot-new-coronavirus-variant
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