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Friday, March 12, 2021

AstraZeneca further cuts EU vaccine supply target to 30M

 AstraZeneca cut its supply forecast of COVID-19 vaccine to the European Union in the first quarter to about 30 million doses, a third of its contractual obligations and a 25% drop from pledges made last month, a document seen by Reuters shows.

The shortfall is a further blow to EU’s vaccination plans already being hampered by repeated delays in supply and a slow rollout in some nations.

The AstraZeneca document, shared with EU officials and dated March 10, shows that the company now expects to deliver 30.1 million doses by the end of March, and another 20 million in April.

On Feb. 25, AstraZeneca boss Pascal Soriot told the European Parliament that the company would try to deliver 40 million doses by the end of March.

The document shows that on Feb. 24, the Anglo-Swedish company had estimated a supply of only 34 million doses to the EU for the January to March period, well below its contracted target of 90 million doses.

The new cut follows a decision last week by Italy and the European Commission to block a shipment of AstraZeneca vaccines from Italy to Australia, in the first application of an EU mechanism that allows the bloc to refuse export requests from vaccine makers that do not comply with EU supply contracts.

A spokesman for AstraZeneca declined to comment on Friday.

A person familiar with the situation said that the increased deliveries the company had expected for the first quarter did not materialise because of difficulties in moving vaccines through global supply chains.

The United States, from where AstraZeneca expected to partly supply the EU market, told the EU that it would not export AstraZeneca shots in the near future, Reuters reported on Thursday, citing EU officials.

The company had said its initial supply cuts were caused by production problems in the EU.

‘NOT BEST EFFORTS’

“I see efforts, but not “best efforts”. That’s not good enough yet for AstraZeneca to meet its Q1 obligations,” EU industry commissioner Thierry Breton said on Twitter late on Thursday.

“It’s time for AstraZeneca’s Board to exercise its fiduciary responsibility and now do what it takes to fulfil AZ’s commitments,” Breton added.

AstraZeneca has committed to making its “best reasonable efforts” to meet the targets set in its contract with the EU, which foresees delivery of 300 million doses from December to the end of June. The vaccine was approved for use in the EU in late January.

The AstraZeneca document also shows that the company expects to deliver about 20 million doses to the EU in April, more than half of that in the last week. It includes no forecasts for May or June.

AstraZeneca has committed to supplying the 27-nation bloc with 180 million doses between April and June.

But EU countries since February have updated their vaccination plans to include only half of the contracted doses after AstraZeneca told them it was facing difficulties.

Germany, the largest country in the bloc, is expected to receive 19% of the AstraZeneca supplies to the EU between next week and the end of April, or a total of about 6 million doses, including over 2 million in the last week of the month, the document shows.

France should receive nearly 15% of the total, or about 4.7 million shots. Italy, with almost 14% of the overall expected supplies, is to get 4.4 million by the end of April, the document shows.

https://www.reuters.com/article/us-health-coronavirus-eu-astrazeneca/astrazeneca-further-cuts-eu-vaccine-supply-target-to-30-million-document-idUSKBN2B402Y

AVEO to Collaborate with Bristol Myers on FOTIVDA-OPDIVO combo

 AVEO Oncology (Nasdaq: AVEO) today announced that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate FOTIVDA® (tivozanib) in combination with OPDIVO® (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, in the pivotal Phase 3 TiNivo-2 trial in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure. FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) approved for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies.

The randomized, open-label, controlled TiNivo-2 Phase 3 trial is expected to enroll approximately 326 patients with advanced RCC who have progressed following prior immunotherapy treatment. The study plans to enroll across clinical sites in the United States, Europe, and Latin America. Patients will be randomized 1:1 to receive either FOTIVDA (1.34 mg/QD for 21 days followed by 7 days off treatment) in combination with OPDIVO (480 mg every 4 weeks) or FOTIVDA alone. The TiNivo-2 study’s primary endpoint will assess progression free survival (PFS), with key secondary endpoints to include overall survival, overall response rate and duration of response, and safety.

"With the recent U.S. FDA approval of FOTIVDA in the relapsed/refractory RCC setting, I look forward to further exploring FOTIVDA’s immunomodulatory effects and differentiated tolerability profile in combination with OPDIVO," said Toni Choueiri, M.D., Director, Lank Center for Genitourinary Oncology; Director, Kidney Cancer Center; Jerome and Nancy Kohlberg Chair and Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. "This combination was first explored in the Phase 1/2 TiNivo study, where it demonstrated favorable tolerability and prolonged PFS using the combination of FOTIVDA and OPDIVO in both treatment naïve and previously treated patients with advanced RCC. The TiNivo-2 Phase 3 study is expected to further our understanding of the activity and tolerability of this combination following prior immunotherapy."

Thursday, March 11, 2021

Pfizer vaccine production on the rise as pandemic hits one-year mark

 Pfizer Inc and German partner BioNTech SE will exceed their original global production target for COVID-19 vaccines by as much as 20% this year, as they ramp up production a year into the global pandemic, Pfizer Chief Executive Albert Bourla said on Thursday.

The companies also released real-world data from Israel earlier on Thursday suggesting their vaccine was 94% effective in preventing asymptomatic infections, suggesting it could significantly reduce virus transmission.

“These are stunning numbers that are giving us a clear indication that liberation is coming,” Bourla said in an interview on the one-year anniversary of the World Health Organization declaring COVID-19 a pandemic. “It is a testament to the power of science, and the power of human ingenuity.”

More than 2.7 million people around the world have died from COVID-19 so far.

Bourla - who got his second shot of the vaccine on Tuesday - said the company expects to produce 2.3 billion to 2.4 billion doses this year, exceeding their original target of 2 billion doses.

By the fourth quarter of this year, Pfizer and BioNTech will reach a 3 billion dose a year production run rate, and should be able to produce that much next year, he said.

Pfizer has said it expects revenue of at least $15 billion from its half of the vaccine sales this year.

Middle-income countries will pay around half the price as high-income countries for their doses, and low income countries will get the vaccine at cost, Bourla said.

Pfizer expects to meet its commitment of supplying 120 million coronavirus vaccine doses to the U.S. government by the end of March. That would require delivering roughly 60 million doses over the next three weeks.

“Those have already been manufactured” and are currently being tested for quality, he said.

“Unless a batch (of vaccine) fails, we will be able to provide them. Our track record is that our batches don’t fail,” he said.

Pfizer’s German partner BioNTech began developing the vaccine last January, and the U.S. drugmaker signed on in early March as the health crisis accelerated. Their vaccine received its first regulatory authorizations in December.

As of Wednesday morning, Pfizer had delivered over 60 million doses of its vaccine in the United States, and nearly 49 million of them have been administered, according to data for the Centers for Disease Control and Prevention. Nearly 33 million Americans have been fully vaccinated with one of the three authorized vaccines.

In the United States, the vaccine is authorized for use in people aged 16 or older. Bourla said the company plans to submit data for children aged 12 to 16 very soon.

He said his assumption was that the vaccine should be authorized for that age range by the fall, adding that data on children aged 5 to 11 can be expected by year-end.

https://www.reuters.com/article/us-health-coronavirus-pfizer/pfizer-vaccine-production-on-the-rise-as-pandemic-hits-one-year-mark-idUSKBN2B32HN

So What Can People Actually Do after Being Vaccinated?

 The first raft of stories in the wake of the acceleration of the COVID-19 vaccine rollout in the U.S. centered on all the things the newly vaccinated among us can and cannot do, as if we were working off a master list of approved activities.

Like so many things associated with this pandemic, the truth is nowhere near that clean. No such list exists, and even the Centers for Disease Control and Prevention (CDC) has only issued recommendations, not requirements. Community and regional medical metrics come into play, and politics will carry its own dark weight when it comes to local or statewide decisions in areas as critical as masking, capacity in buildings and restaurants and so on.

Even such basic concepts as risk are subject to variances of opinion, as I discovered while soliciting input from several medical experts across the country and abroad. And as there are no clinical trials to address many of these questions, scientists are left to provide their best recommendations based on their interpretation of risk tolerance, both at an individual and population level, and their scientific knowledge of the virus and its kinetics.

First, here’s where the experts agree: The levels of protection provided by all of the available vaccines in clinical trials were extraordinary when it came to preventing severe disease, hospitalization and death. While the new variants pose a threat, most of those interviewed believe that current vaccines should provide reasonable protection there, too.

“To date, based on the studies by Johnson & Johnson in South Africa and Brazil, the vaccines will likely prevent hospitalization and death caused by the variants,” Paul Offit, an internationally recognized expert in virology and immunology and director of the Vaccine Education Center, wrote in an e-mail.

This is not the same as saying that a safe haven has been established. Most experts concurred that although we’ve seen declines in new daily cases of coronavirus since early January, the U.S. is still experiencing high levels of transmission of the virus, with approximately 60,000 new cases reported daily and about 1,500 deaths every day. These remain very high numbers.

“Our return to normalcy will be in two phases and is driven by two factors: the level of virus transmission in our communities and the proportion of people fully vaccinated,” says William Moss, executive director of the International Vaccine Access Center and professor of infectious disease epidemiology at the Johns Hopkins Bloomberg School of Public Health. Because of the high levels of viral spread and the low proportion of U.S. citizens fully vaccinated, Moss says, things like masking, social distancing, hand washing and avoiding large crowds remain critically important.

Vaccination efforts across the country have ramped up significantly in recent weeks. Currently, in the U.S., 2.1 million people are being vaccinated daily. More than 93 million doses have been administered in total, with 18 percent of Americans having received one dose and 9 percent two doses. President Biden has said that coronavirus vaccine should be available to all U.S. adults by the end of May.

But the questions of mobility, interaction and risk assessment are thorny ones. The good news (and, for many, the best news) is a general consensus that vaccinated people should be able to get together with others who’ve also received the vaccine, ditching masks and distancing precautions. The risk of infecting one another in these so called “immunity bubbles” is pretty low; Anthony Fauci, the president’s chief medical officer, concurs that small, maskless social gatherings in the home of those who are “doubly vaccinated” should be fine. New CDC public health recommendations for fully vaccinated people published March 8 likewise allow for fully vaccinated people to visit with other vaccinated people in a private setting, unmasked, without distancing.

Beyond that, though, the line becomes harder to draw. Monica Gandhi, an infectious disease physician and professor of medicine at the University of California, San Francisco, argues that those who’ve been vaccinated “are protected from severe COVID-19 infection at this point, and should feel free to start engaging in activities that they miss.” Those, she says, include going to an indoor bar or restaurant and attending movies, albeit with masking and distancing protocols in place—a level of reengagement that few other experts are willing to encourage at this time. (The CDC’s updated recommendations state that while the risk of going to a gym or dining indoors at a restaurant is lower for fully vaccinated people, health precautions should still be taken given the higher risk in these settings.)

Gandhi also suggested that indoor weddings, church services and school classrooms, among others, should be in play, again with masking, distancing and ventilation needs duly observed. That, for some experts, is a threshold they’re reluctant to cross because of viral spread issues indoors. Paul Griffin, an infectious disease specialist at the University of Queensland in Brisbane, Australia, emphasizes the need to try to hold these larger events outside when possible, restrict anyone unwell from attending, maintain social distancing (perhaps by spacing chairs further apart) and provide good ventilation by opening windows when possible.

If cases are running high in the community and social distancing cannot be maintained, Griffin says he would recommend mask-wearing and limiting the number of attendees. Some experts go further, concurring with the CDC’s latest guidance, which advise against “medium-or large-sized gatherings, regardless of vaccination status. Says Moss, “The recommendations will loosen when we see further declines in cases, hospitalizations and deaths.”

The experts I consulted are dealing with incomplete information, of course. We all are. And one of the things we don’t yet know, but would love to learn, is how well these vaccines actually control the spread of the virus. The answer to that question may well shape the largest body of medical advice when it comes to those who’ve already received their shots.

While the vaccine protects an individual well from symptomatic COVID-19, we are not sure whether that person can still develop asymptomatic infection (and, theoretically, then unknowingly pass the disease on to others). “If we want to get on top of the pandemic,” says Griffin, “we still need to try and reduce the chance of the virus being spread…. If a proportion of people can stay away from venues where people have a high probability of interacting, for example people choosing takeaway food or working from home when they can, then the chance of the virus being transmitted is greatly reduced and the effect of the vaccine rollout will be increased.”

Early real-world data suggest that vaccines likely will help prevent this asymptomatic transmission of the virus, but the information’s incomplete. Non-peer-reviewed data from the Israeli Health Ministry and Pfizer  demonstrated an 89 percent reduction in both symptomatic and asymptomatic infections following vaccination, although some scientists believe this finding may be overstated. A vaccine trial by Johnson & Johnson, meanwhile, found that its vaccines prevented asymptomatic infection in 74 percent of recipients.

Vaccinated healthcare workers in the U.K. showed an 86 percent decrease in asymptomatic infection versus those who were not vaccinated, and another preliminary study showed a fourfold reduction in viral load for infections occurring weeks after Pfizer’s first vaccine, which may equate with reduced infectiousnessModerna’s vaccine data also hinted that it reduced asymptomatic infections. “It seems very likely that the vaccines in use will reduce transmission,” says Griffin, “but we don’t have good data on it to be able to say how much.”

Gandhi is among those who believe that returning to work in person, if other co-workers have been vaccinated, is “perfectly safe.” Griffin, meanwhile, cautions that even with outdoor events, “the risk is obviously not zero.” The use of basic mitigating strategies, experts agreed, is going to remain front and center of any loosening of community restrictions that might result in the mixed company of those who have and have not received vaccines.

Can vaccinated grandparents travel to visit family? “Vaccinated grandparents are completely safe from severe disease with COVID-19 with the vaccines, and should finally see their family again!” says Gandhi. Based on accumulating evidence showing that “vaccines prevent transmission,” she says, “If there are grandchildren in the household who are not vaccinated, the grandparents will not transmit virus to them.” The CDC agrees that fully vaccinated individuals (or grandparents) may gather with unvaccinated people from a single household in a private home, among those who are at low risk for severe COVID-19 disease,” without masking or distancing indoors. If unvaccinated people come from several households, then the visit should occur outdoors (or in a well-ventilated space) with proper precautions.

Why have scientists been so cautious? Gandhi believes it is partly that the vaccines themselves appear almost too good to be true. “But they are honestly that good,” she added. “I think we should take the data as it comes and has been coming for vaccines reducing transmission, and modify our recommendations accordingly.” (Some other experts said they felt that grandparents should assess the risks versus benefits —and if they choose to travel, consider masking and distancing until cases decline further.)

The idea of travel, particularly air travel, remains problematic. While some authorities believe that once you’ve been vaccinated, such travel is relatively low-risk (assuming you maintain masking requirements), others are more cautious, suggesting that air travel should wait until greater herd immunity is achieved. At a CNN Global Town Hall, Fauci warned that vaccination should not be considered a “free pass to travel.” The CDC did not update its travel recommendations on March 8, and continue to advise that unnecessary travel be avoided.

And we don’t know about the connection between vaccination and long COVID. If those who’ve had their shots can still develop asymptomatic or mild disease, are they also susceptible to becoming one of the group known as long haulers, those who may carry the symptoms for many months after illness?

Early evidence is encouraging, but slim. At Yale University, Akiko Iwasaki tweeted recently about an informal survey of 473 long-COVID patients; among those who were two weeks past their first vaccination, 27 of the respondents said their prolonged symptoms were slightly better, while 14 percent said they were slightly worse. Says Griffin, “While there is limited if any data on this (subject) to date, given the fact that we know the vaccines are not only very safe but very effective at reducing symptomatic infection and particularly severe disease, it would seem highly plausible that the longer-term manifestations or long COVID, will also be reduced.”

In the end, the experts say, local conditions are going to matter tremendously. Their suggestion to the newly vaccinated: Include in your decision-making how high background rates of disease are in your community, what emerging variants may be circulating, any personal risk factors that may place you or others around you at greater risk, and the real, time-proven knowledge that vaccines are not bulletproof.

Beyond that, people will make their choices. “The only thing we can/should really do as scientists, in my opinion, is to provide people with some reasonable assessment of their risk given an exposure—but even this is very difficult to do in practice,” said Kate Grabowski, an infectious-disease epidemiologist at Johns Hopkins Bloomberg School of Public Health.

We will know more in a few months when vaccine studies looking at transmission conclude and more data emerge. In the meantime, every new vaccination gets us closer to herd immunity. “It will be low case numbers, complemented with rigorous contact tracing and high proportion of vaccinated individuals that will eventually get us to safety—and back to normal lives,” says Moss.

Finally, a personal note: As a higher-risk individual, I found being vaccinated an incredibly liberating feeling, a weight off my shoulders. At the vaccination center where I work, every time I vaccinate someone and hand them a Jolly Rancher lollipop, we smile and celebrate a genuinely momentous occasion. The development of highly effective vaccines in less than a year is one of the most remarkable medical feats of our time. Now, we just need to see it all the way through.

https://www.scientificamerican.com/article/so-what-can-people-actually-do-after-being-vaccinated/

Biden to direct states to make all adults eligible for Covid vaccine by May 1

 President Joe Biden announced Thursday evening that he will direct states to make all adults, ages 18 and up, eligible for the coronavirus vaccines by May 1.

Biden, in his first primetime address to the nation, also said that Americans should hopefully be able to gather in small groups to celebrate the Fourth of July.

Biden delivered the announcements as he marked the one-year anniversary of the shutdowns due to the Covid, reflecting with anguish on the pandemic’s devastation while offering a glimpse that better days could soon be coming — if Americans don’t get complacent.

“If we all do our part, this country will be vaccinated soon, our economy will be on the mend, our kids will be back in school, and we’ll have proven once again that this country can do anything,” Biden said.

Biden’s address from the East Room of the White House began just after 8 p.m. ET, and lasted about 25 minutes.

The primetime event came hours after Biden signed into law the $1.9 trillion Covid relief bill, which he had aggressively pushed Congress to pass during his first 50 days in office.

The speech also came as the United States administered a record number of vaccines over the weekend. The Centers for Disease Control and Prevention administered 2.9 million vaccines on Saturday, a record, and 2.4 million on Sunday, according to the agency’s latest tally. The numbers are subject to revisions as more data becomes available to public health officials.

Biden is set to embark on a nationwide tour next week to tout the first major legislative accomplishment of his administration. The president will depart Tuesday for Delaware County in Pennsylvania, an electoral swing state that was key to Biden’s victory over former President Donald Trump.

https://www.cnbc.com/2021/03/11/covid-vaccine-biden-will-direct-states-to-make-all-adults-eligible-by-may-1.html

COVID-19 Long Haulers: Persistent Shortness of Breath Due to Treatable Nerve Injury

 Persistent shortness of breath in COVID-19 long haulers may be due to a treatable nerve injury. This is a reminder that shortness of breath is not always pulmonary. 


Sandy is a 42-year-old previously healthy woman who presented with a four-month history of an inability to have conversations or do Zoom meetings without feeling out of breath.

Her chest X-ray (CXR) and chest computerized tomography (CT) scan were normal. However, she had an unusual abnormality on her spirometry lung breathing test with flattening of the inspiratory curve.

She had clinical symptoms of mild COVID-19 disease in March 2020. However, she was not tested due to lack of access.

An ear, nose, and throat (ENT) examination of her larynx (voice box) in July 2020 showed abnormal closing of her vocal cords during quiet breathing. This is a time when they should have been open. This was identified as a paradoxical vocal fold movement disorder.

Treatment was instituted and included following a strict low-acid diet and doing speech therapy via telemedicine (due to the ongoing pandemic). Six weeks later, Sandy was able to carry on full conversations and run Zoom meetings without any shortness of breath. And, her examination was normal.

COVID-19 “long haulers” and shortness of breath

Persistent shortness of breath (SOB) long after recovery from presumed or documented COVID-19 infection is a vexing and troublesome symptom for untold numbers of people.[1] 

SOB is a prominent symptom in people with what has come to be known as the COVID-19 “long hauler” syndrome.[2] In the United Kingdom, it is referred to simply as COVID “long”. What the “long” refers to is long after people ostensibly “recover” from COVID-19 there may exist a persistence of a variety of symptoms that seem to defy further diagnosis and treatment.

Two types of COVID-19 long haulers

According to Dr. Anthony Komaroff, MD, Editor in Chief of the Harvard Health Letter, there are two basic types of COVID-19 long haulers.[3]

  • Those who experience some permanent damage to their lungs, heart, kidneys, or brain that may affect their ability to function.
  • Those who continue to experience debilitating symptoms despite no detectable damage to these organs.

Fauci weighs in on the cause of COVID-19 long haulers’ symptoms

There are several theories as to why there are persistent symptoms. One of the most popular theories comes from Dr. Anthony Fauci MD, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Dr. Fauci feels that the COVID-19 patients in the “no detectable organ damage” group have a post-viral syndrome called myalgic encephalomyelitis. This was previously known as chronic fatigue syndrome.[3] 

Once this diagnosis is made, and because COVID-19 is a new disease, very little hope is offered. We believe that we have identified a treatable diagnostic possibility that does in fact offer hope to these patients.

Persistent respiratory symptoms after other viral illnesses are common in COVID-19 long haulers

Those of us dealing with post-viral syndromes are quite familiar with upper respiratory-type symptoms following other viral-mediated illnesses, including

  • mononucleosis
  • severe acute respiratory syndrome. 

In the otolaryngology (ENT) world, we constantly treat viral illnesses from unknown sources that cause loss of smell, hearing, and voice—and also cause chronic cough and shortness of breath.  

This past June, New York City-based ENT and Allergy Associates, the largest single-specialty group of ear, nose, throat and allergy physicians in the United States, began to see patients with persistent SOB and/or cough.

They reported that they were quite ill around the time of the peak of the COVID-19 pandemic in New York City in March and April 2020.  In a recent study we published, along with Byron Thomashow MD, one of the foremost lung specialists, or pulmonologists, at the Columbia University Medical Center, we described a TREATABLE cause for the shortness of breath seen in these patients.[4]


Common characteristics of our group of COVID-19 long haulers

The key to figuring out what may be the cause of the symptom was to make an accurate diagnosis. The group of patients we saw had the following common characteristics:

  1. Cough, fever, SOB between March and May 2020, not serious enough to warrant being hospitalized.
  2. The SOB persisted for 4-12 weeks at the time we first saw them.
  3. The SOB was generally not waking these patients up at night. It was also not affecting their exercise tolerance. In fact, they often reported feeling breathing difficulties after their activity. Talking, shouting, singing, karaoke, and odors typically brought on the SOB.  
  4. Due to limited access, only a handful of the group of patients we saw were able to get tested for COVID-19. Of the group that got tested, only a few developed antibodies to COVID-19. Further, only one of the few tested with the polymerase chain reaction test was positive.
  5. Imaging, including CXR and/or CT scan of the chest, were all unremarkable.
  6. A handful of patients were able to obtain a lung function test called spirometry.[5] All of them showed a specific pattern on the flow-volume loop where there was flattening of the inspiratory curve. This means when the patient took a breath in, there was evidence of impaired airflow INTO the lungs. However, they had a normal expiratory curve, indicating normal airflow OUT of the lungs.

Normally when one is sitting, breathing quietly, one’s vocal cords, or vocal folds, are open, not shut. They close when you swallow, to protect the lungs. And they close and vibrate when you speak, to make sounds. Then, they open again.

The vocal folds can be comfortably examined with a tiny camera while the patient is awake in our exam rooms.

In all of these patients, their vocal folds were not moving in normal synch with their breathing—that is, they were closing more than 50% of the airway during quiet breathing. This is the opposite of what typically happens in a healthy individual.

The abnormal vocal fold closure could be brought out by having the patient say the five-word sentence “we see three green trees” and observing the vocal folds slowly closing afterward – for as long as nine seconds. During this time the patients feel as if they can’t catch their breath.

We concluded that the persistent vocal fold closure gave the patients their SOB. The flattening of the inspiratory curve on spirometry corroborated the laryngeal exam findings. 

This is different than laryngospasm where the vocal folds suddenly slam shut for prolonged periods of time. It also has a different symptom profile. 

What is vagal neuropathy?

The name for this abnormal vocal fold movement during breathing is vocal fold dysfunction. It is also called paradoxical vocal fold movement disorder.[6]

It is often caused by inflammation of the vagus nerve.  The vagus nerve is one of the 12 cranial nerves that emanate from the brain. It governs breathing, talking, swallowing, among other vital functions.

If a viral illness causes inflammation of the vagus nerve, then breathing is typically going to be disturbed. This post-viral vagus nerve trauma is also called “vagal neuropathy”.

 One of the reasons it has traditionally been difficult to make the diagnosis of post-viral vagal neuropathy is that most people are unable to recall when or if they had a viral illness. This is especially true if the illness took place years ago.

In the current time of coronavirus, patients seem to be paying much more attention to when they began to feel ill.  

Speech therapy and a low acid diet can treat vagal neuropathy in COVID-19 long haulers

The good news here is that the cause of this abnormal breathing pattern can be treated with two non-invasive, non-pharmacologic means. We used a combination of approaches:

  • physical therapy
  • diet modification techniques.

The therapy is called respiratory retraining. This involves increased resistance breathing exercises that are generally administered by a speech-language pathologist. 

A low acid diet also works for these patients. There are a handful of very acidic foods and beverages that have a pH of less than 4. These include 

  • flavored sodas
  • bottled ice teas
  • citrus
  • tomato sauce (tomatoes are okay)
  • vinegar, including apple cider vinegar
  • wine, tend to aggravate the breathing issues.

We recommend that these foodstuffs be avoided.  

Using these two methods, all of our patients had resolution of their SOB.

There is hope for many COVID-19 long haulers who have shortness of breath

As we learn more about COVID-19 and long haulers we see many who have persistent SOB who have normal lung imaging. They are often told nothing further can be done for them. However, we have identified a possible, treatable cause for their symptoms.

In patients with persistent SOB, with or without cough, where the pulmonary imaging is unremarkable, one should obtain both a spirometry test and an ENT evaluation. This should happen whether or not they tested positive for, or have antibodies to, COVID-19; but certainly in those with positive testing.

This symptom may be due to a virus-related vagus nerve injury. The spirometry has a typical abnormal pattern and the neuropathy is readily identified with an office-based examination of the vocal folds.

Once diagnosed, the patient can receive the correct targeted treatment, and, just like our patient Sandy, they can return to enjoying their previously good quality of life.

https://thedoctorweighsin.com/covid-19-long-haulers-persistent-shortness-of-breath/

J&J to make up to 3 bln COVID-19 vaccines in 2022

 Johnson & Johnson's chief scientist said the company expects to produce up to 3 billion doses of its COVID-19 vaccine next year, after the European Union approved the one-shot immunization on Thursday.

The company is bringing on three manufacturing plants to produce the key drug substance. It also will have seven plants globally that will handle final production steps and bottling into vials known as fill and finish.

"All these will function together to deliver the 1 billion by the end of the year," Dr. Paul Stoffels, J&J's chief scientific officer, said in an interview.

"Next year, we can do more than two billion vaccines, and even up to three if we maximize capacity. With Merck on board, we will be north of 2 billion," he added, referring to a recent agreement for rival Merck & Co to produce J&J's vaccine.

Stoffels also said he was confident J&J will be able to deliver a planned 55 million doses to the European Union in the second quarter. An EU official told Reuters this week that J&J had flagged possible supply issues that may complicate these plans.

“We trust that we can deliver close to that amount in Q2," Stoffels said, adding that final production steps would be the biggest challenge.

"It’s the fill and finish which was the critical part and there we learned we had later access, we started later and had later access to facilities,” he said.

J&J's shot is the fourth to be endorsed for use in the EU after vaccines from Pfizer/BioNTech , AstraZeneca Plc and Moderna Inc.

Europe is scrambling to get immunization campaigns off the ground after an early supply shortfall from Pfizer, since resolved, and more persistent issues with AstraZeneca.

J&J’s vaccine is expected to be used widely around the globe because of its one-shot convenience and logistical advantage of being shipped and stored at normal refrigerator temperatures. Both the Pfizer/BioNTech and Moderna vaccines require two doses and must be shipped frozen.

Thursday's approval included authorization in Europe of Maryland-based Emergent Biosolutions Inc, which is making active drug substance for the vaccine.

"Emergent is a very critical supplier. It’s important for both the U.S. and Europe and other parts of the world," Stoffels said, adding it can deliver enough drug substance for "up to a billion vaccines a year."

Stoffels said in the United States, the company was only allowed to seek emergency use authorization for one manufacturing plant to produce drug substance.

Initial U.S. doses are being made at the company's plant in Leiden, the Netherlands. J&J is awaiting U.S. approvals of the Emergent plant for drug substance, and for Catalent Inc , a contract manufacturer that will handle fill and finish from a new manufacturing line in Bloomington, Indiana.

Stoffels said as soon as J&J received U.S. authorization for the vaccine, U.S. regulators started reviewing the company's additional production plants.

He said early "hiccups" have been resolved and the company expects to deliver on its promise of 100 million doses before the end of June.

In Europe, Stoffels said the company plans to significantly scale up production of its Leiden plant. Additional capacity will come on board likely over the summer, he added.

Indian drugmaker Biological E Ltd will handle both drug substance and fill and finish for J&J's vaccine. The company's managing director told Reuters last month that Biological E was looking to contract manufacture roughly 600 million doses of J&J's COVID-19 vaccine a year.

Biological E is in the process of installing and validating equipment in the plant, which Stoffels said he expects to be ready in the second half of this year.

https://finance.yahoo.com/news/j-j-3-bln-covid-203821384.html