Roche is partnering with Moderna to include a COVID-19 antibody test in the mRNA specialist’s ongoing vaccine trials, the Swiss drugmaker said on Wednesday, potentially demonstrating if the vaccine is working.
Roche said the test, which received U.S. Food and Drug Administration emergency use approval in November, can provide quantitative evidence of the presence and levels of antibodies that develop in response to Moderna’s vaccine candidate.
Moderna’s vaccine, which in late-stage trials with more than 30,000 participants showed efficacy of 94% in preventing COVID-19, is designed to trigger an antibody response to proteins found on the coronavirus spike’s receptor binding domain, the part of the virus that gains entry to human cells.
Roche said its test, conducted in a laboratory setting and requiring a blood draw, can establish a correlation between vaccine-induced protection and levels of receptor-binding domain antibodies.
“This could play a role in assessing if, or when, an individual needs revaccination, or in helping to answer other clinically relevant questions,” Roche said in a statement.
Until now, demand for so-called molecular tests to detect active COVID-19 disease from Roche and other manufacturers has far exceeded supply, though there has been less demand for so-called antibody tests that help determine if a person has been exposed to the new coronavirus and has recovered.
Roche hopes with new tests like the one it is pairing with Moderna’s trial will help boost demand for antibody tests, too.
India’s health ministry rejected reports on Wednesday that the country’s drugs regulator had declined emergency authorisation for the AstraZeneca COVID-19 vaccine candidate and one developed locally by Bharat Biotech and the government.
Broadcasters NDTV and CNBC-TV18 reported that India’s Central Drugs Standard Control Organization (CDSCO) had sought more data from the drugmakers after deliberating on applications made this week.
A source with direct knowledge of the matter told Reuters that a decision on the vaccines would be taken “in toto” and it was too early to say whether they would be rejected or accepted.
Another said: “The CDSCO just wants more data on efficacy and safety before making a decision. It is part of the process”.
Both sources declined to be named as they were not authorised to talk to the media.
India’s health ministry denied the media reports in a statement on Twitter. The government had said on Tuesday that some vaccines may be approved in the coming weeks.
The Serum Institute of India, which is the local manufacturer of the AstraZeneca vaccine, only applied for emergency approval on Monday.
The SII did not immediately respond to a request for comment. Bharat Biotech, whose application reached the government on Tuesday, declined to comment. The CDSCO did not immediately respond to a request for comment.
India, the world’s biggest vaccine maker, has reported nearly 10 million COVID-19 infections, putting it behind the United States globally in overall cases.
NDTV said the CDSCO did not consider a similar application from Pfizer Inc because their U.S. experts could not attend the Wednesday meeting. A Pfizer spokeswoman did not immediately respond to a message seeking comment.
Companies and industry groups lobbying to get their U.S. workers to the front of the line for COVID vaccination are running into a patchwork of state plans and confusion over who is essential, and who is not.
Inoculation against the disease caused by the novel coronavirus is key to safely reopening large parts of the economy and reducing the risks of illness at crowded meatpacking plants, factories and warehouses.
But before one needle has entered the arm of an American worker, confusion has broken out over who exactly is considered essential during a pandemic.
With initial vaccine doses limited and strong federal guidance lacking, it has fallen to U.S. states to determine who will be first in line to receive a vaccine, and who will have to wait well into next year.
State vaccine distribution plans reviewed by Reuters showed broad discrepancies over who would be considered essential, with some states clearly outlining specific worker groups and others not providing any clarity.
Generally, states have broad discretion when it comes to vaccine distribution and policy and are able to issue vaccination mandates for their residents.
Many states have so far followed federal guidance to give meat and food processing industry workers space in the line, but some are slowly moving away, said Mark Lauritsen, a former hog slaughter worker who now advocates on behalf of about 250,000 meatpacking and food processing workers under the United Food and Commercial Workers union.
“For example, Colorado has not moved meatpacking and meat-processing as high as some other states. So we’ll be directing a lot of our effort towards places like Colorado where we may be moved down the food chain.”
“We’re a union that has members in every state so we will be talking to every state to make our case as to where our place in line should be...Everybody is going to be jockeying for a place in line.”
More than 20 large industries have urged officials to prioritize their workers, including individual companies such as ride-hailing company Uber Technologies Inc and food delivery provider DoorDash Inc and industry groups representing truck drivers, teachers, retail workers and other business sectors.
DoorDash in its letter calling for preferred vaccine access for its delivery workers said the company could also help public health officials communicate vaccine information through its platform.
At least 22 industries, including agricultural companies, cleaning suppliers, dental hygienists, bus drivers and meat packers, also have written to the Advisory Committee on Immunization Practices (ACIP), an independent panel of health experts recommending vaccine distribution guidelines to the U.S. Centers for Disease Control and Prevention.
WHO IS ESSENTIAL?
“We’re hopeful that local health officials start jumping on this quicker rather than later so that there’s some guidance and some better sense of how to be efficient with the essential workforce,” said Bryan Zumwalt, executive vice president of public affairs for the Consumer Brands Association.
The group representing consumer products makers including Procter & Gamble Co and Coca-Cola Co, has sent letters to nearly all 50 U.S. states and federal officials, urging their nearly 1.2 million workers to be prioritized for a vaccine.
ACIP to date has only recommended healthcare personnel and residents of long-term care facilities should receive the vaccine first - a priority not disputed by any industry or state. ACIP members did not respond to a request for comment or declined to comment pending the discussions.
While some states have said they would await the committee’s further recommendations, others went ahead and developed their own vaccine distribution priorities, a review of COVID-19 vaccine distribution plans showed.
U.S. President-elect Joe Biden has criticized President Donald Trump’s lack of a coordinated plan to distribute coronavirus vaccines, but it is not clear whether the federal government could overwrite state distribution plans.
In New York, essential frontline workers regularly interacting with the public, such as pharmacists, grocery store workers and transit employees, are slated to receive the vaccine in a second distribution phase, while Florida included all essential workers on a U.S. Homeland Security list.
But that Homeland Security department list, spanning more than 25 major industries, makes up nearly 70% of the U.S. labor force, according to researchers at the National Bureau of Economic Research.
Georgia’s plan said the state was working with various industries, including poultry plants, manufacturers and warehouse distributors.
In North Carolina, which has one of the most detailed distribution plans spanning nearly 150 pages, workers in meatpacking, seafood, poultry and food processing, transportation and retail would be included in an early phase so long as they had at least two chronic conditions that put them at high risk.
Pennsylvania’s distribution plan on the other hand only includes three pages, stating merely that those “contributing to the maintenance of core societal functions” would be prioritized.
Shortly before school began in September, administrators in Schenectady, New York, laid off more than 400 teachers, aides and other employees -- roughly one out of every five school workers.
Now teachers in this aging industrial city outside Albany must handle classes of up to 32 students, with few aides to help. Pre-kindergarten has been canceled and high school is taught entirely online. A support program for kids who often come to school hungry and unwashed has been eliminated.
“Our poor kids are suffering, and we really don’t know who to blame,” said Carol Mould, who quit her job as a nurse to supervise her 6-year old and 9-year-old boys.
With budgets battered by the coronavirus pandemic, state and local governments across the United States have laid off nearly 700,000 workers this year, according to U.S. government data, equal to 8.4% of the workforce. Advocates warn that Schenectady’s experience could become commonplace if Washington does not provide more help.
“Some people say that maybe we’re just the canary in the coal mine,” said schools Superintendent Aaron Bochniak.
Congress approved $280 billion in state and local aid in March, but has been deadlocked since then, with some Republicans objecting to aid for what they view as free-spending local and state governments. Lawmakers are scrambling to pass some form of coronavirus stimulus in a year-end spending package, though it is not clear if it will include school aid.
Declining tax revenues and additional costs due to the pandemic, such as buying laptops for students who need them to work from home, will amount to a nationwide educational shortfall of up to $246 billion, or 18% of projected spending, over the next two years, according to Michael Griffith, a senior researcher at the Learning Policy Institute.
RAINY-DAY FUNDS RUNNING DRY
States have been able to cover much of the gap so far by tapping rainy-day funds using onetime budget maneuvers. That probably won’t be possible next year.
“Everything you can do to cushion the blow as a state has been done at this point,” Griffith said.
At least 14 states cut education spending this year in response to the COVID-19 crisis, according to the National Conference of State Legislatures.
Some communities, like Littleton, Colorado, voted to raise property taxes to offset state cuts. Others, from Vancouver, Washington to Frederick County, Maryland, have handed out hundreds of pink slips.
In New York, the state government reduced school payments by 20% in July, August and September, and warned it might have to extend those cuts through the school year. So far, it has not done so.
Because that aid is tilted toward poorer schools, affluent areas have been less affected.
The whiter, wealthier suburbs outside Schenectady boosted school budgets by 2% over the summer, in line with previous years.
In Schenectady, a former manufacturing hub of 66,000 people, the city government raised property taxes and trash-collection fees. The school board laid off 423 teachers, janitors and other workers.
Many students were already struggling before the pandemic. Only 16% of grade schoolers were found to be proficient in math in 2019, one-third the statewide average.
State aid accounts for 69% of the school budget, and officials decided they needed to slash costs immediately.
Layoffs fell most heavily on the social workers and teachers’ aides who had been hired to support students who were struggling with academic or behavior problems -- a reflection, educators say, of difficult home lives in a city where nearly one in five households lives in poverty.
Those students are now more likely to fall behind, officials say. “It’s an awful thing as a school community to grapple and deal with,” said Bochniak, the superintendent.
Because state aid is partially determined by a district’s overall budget, this year’s could lead to lower levels of state aid for years to come.
In Schenectady, those laid off in September are trying to move on with their lives. Social worker Lindsey Esposito has found work elsewhere, but says she worries that her former students are not getting the help they need.
“These kids are struggling. They were struggling before COVID, and everybody looks past them,” she said. “You get frustrated about it, but you just figure you’ve got to move on.”
Ionis Pharmaceuticals (NASDAQ:IONS) has the potential to launch more than six new products through 2026.
The expectation is that the implementation of this strategy will drive double-digit revenue growth and substantial earnings growth.
Company seems to be positioned for a strong 2021 and beyond.
Company estimates the total market opportunity for the indications targeted by its pipeline is well in excess of $15B, with a significant portion from its wholly owned medicines.
"In 2020, we pursued an aggressive agenda focused on building our commercial plans and capabilities, progressing the Ionis-owned pipeline, advancing our technology and growing our leadership position in RNA-targeted therapeutics. We are pleased to say that we delivered against all these objectives. We invested in building our commercial plans and capabilities and began implementation. These actions were accelerated through the acquisition of our commercial affiliate Akcea. We have also progressed and substantially expanded the Ionis-owned pipeline. In addition, we have six Phase 3 trials underway, initiated 13 Phase 2 trials, achieved multiple, positive clinical proof-of-concept readouts, and advanced new delivery platforms." said Brett P. Monia, Ph.D., CEO.
PEOPLE with "significant allergies" have been warned not to get Pfizer's Covid-19 vaccine after two NHS workers fell ill on V-Day.
The healthcare workers developed symptoms shortly after having the jab on the first day of the UK's mass vaccination programme, officials said.
They both have a significant history of allergic reactions - to the extent where they need to carry an adrenaline pen with them, NHS England said.
Officials confirmed the staff members - who were among thousands to get the jab yesterday - are now recovering and all trusts involved in the vaccination programme have been informed.
The Medicines and Healthcare products Regulatory Agency (MHRA) has given precautionary advice that anyone who has a history of "significant" allergic reactions to medicines, food or vaccines should not receive the vaccine.
"Significant" means a person has suffered anaphylaxis - a potentially life-threatening reaction which can cause breathing difficulties, confusion, vomiting or collapse - or needs to carry an EpiPen.
Anyone scheduled to receive the vaccine on Wednesday will be asked about their history of allergic reactions.
RULED OUT
The MHRA advice states: "Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer/BioNtech vaccine.
"Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available."
Professor Stephen Powis, national medical director for the NHS in England, said: "As is common with new vaccines the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday.
"Both are recovering well."
The news will come as a huge blow to people with allergies.
What is a common vaccine reaction?
According to the NHS, the most common side effects of vaccination are:
the area where the needle goes in looking red, swollen and feeling a bit sore for 2 to 3 days
babies or young children feeling a bit unwell or developing a high temperature for 1 or 2 days
It's "rare" for anyone to have a serious allergic reaction to a vaccination, the NHS says.
If this does happen, it usually happens within minutes.
The person who vaccinates you or your child will be trained to deal with allergic reactions and treat them immediately. With prompt treatment, you will make a good recovery.
The Pfizer/BioNTech jab showed the following side effects in trials:
Like all vaccines, the new coronavirus vaccine can cause side effects, although not everybody gets them.
Very common (Likely to affect more than one in ten people)
Pain at injection site
Tiredness
Muscle pain
Chills
Joint pain
Fever
Common (Likely to affect up to one in ten people)
Injection site swelling
Redness at injection site
Nausea
Uncommon (May affect one in 100 people)
Enlarged lymph nodes
Feeling unwell
The NHS says all vaccines are thoroughly tested to make sure they will not harm you or your child.
It often takes many years for a vaccine to make it through the trials and tests it needs to pass for approval.
But scientists have been working at speed to develop a Covid jab in under one year.
This has been possible because of huge funding, global collaboration, and because there was high transmission of the virus globally to test it.
Experts have said "no corners have been cut" in testing Covid vaccines.
Once a vaccine is being used in the UK it's also monitored for any rare side effects by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA accounced on December 2 the Pfizer/BioNTech was safe and effective.
An estimated 10 to 40 per cent of the population have an allergy, according to Allergy UK - however most of these will not be severe.
Some of the most common allergies, according to the NHS, are to foods like nuts, fruit, shellfish, eggs and cow's milk, and medicines - such as ibuprofen, and antibiotics, such as penicillin.
The two NHS staff members were among thousands of Brits who became the first people in the world to receive the Pfizer vaccine yesterday.
Elderly British patients who were first in line to get the jab urged sceptics to take the vaccine for the good of the country.
The MHRA added should anyone else given the jab suffer any suspected adverse reactions to report it via theYellow Card scheme.
Dr June Raine, chief executive of the MHRA, said today the cases were being investigated after regulators were told of the reactions on Tuesday night.
She added: "I may share with the committees that even last evening, we were looking at two case reports of allergic reactions.
"We know from the very extensive clinical trials that this wasn't a feature."
'WELL TOLERATED'
Pfizer said today the vaccine was "well tolerated" during the trials with "no serious safety concerns".
A spokeswoman for Pfizer said: "We have been advised by MHRA of two yellow card reports that may be associated with allergic reaction due to administration of the Covid-19 BNT162b2 vaccine.
"As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation."
Pfizer said the trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.
According to Pfizer’s clinical trial protocol, people were not enrolled in the trial if they had a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)”.
It is not clear if people with severe allergies related to medicines or food were included.
Professor Peter Openshaw, past-President of the British Society for Immunology and Professor of Experimental Medicine at Imperial College London, said allergic reactions were monitored in the trial participants.
Referring to an analysis by the FDA published on Tuesday, he said: "The occurrence of any allergic reaction was one of the factors monitored in the phase 3 clinical trial of this Pfizer/BioNTech Covid-19 vaccine, the detailed data from which was released yesterday.
"In this, they reported a very small number of allergic reactions in both the vaccine and placebo groups (0.63 per cent and 0.51 per cent)."
Paul Hunter, a professor in medicine at University of East Anglia, told The Sun: "Allergic reactions to vaccines do occur and are immunizations are often contraindicated in for people who have had a previous severe reaction.
"This is why people who have had the vaccine are required to hang around for a while after having had their injection. If you are still in the clinic an allergic reaction is much easier to deal with.
"I don’t think this is particularly unexpected and I do not think it should interfere with roll out of the vaccination programme."
Dr Andrew Preston, a reader in microbial pathogenesis, Department of Biology and Biochemistry at University of Bath, told The Sun: "Allergic reactions arise from a trigger of an aspect of the immune system by a specific stimulus.
"So it will be a case of working out what the signal is from within the vaccine.
"There is an obligation to not knowingly risk the health of trial participants, so often they will exclude groups for which there might be a predicated risk.
"For example, people with major immunocompromisation would be excluded from trials of live vaccines.
"But the bottom line is in these initial trials of tens of thousands of people, you can’t include every possible set of conditions.
"That’s why no matter how thorough a trial is, there will always be some-people who have a reaction.
"Obviously if this starts to become a significant number then you have to start to consider the cost-benefit at the population level."
Professor Openshaw said there is a "very small chance" of an allergic reaction to a vaccine with all food and medication allergies.
"However, it is important that we put this risk in perspective," he said.
“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.”
MONITORING SIDE-EFFECTS
The vaccine uses mRNA technology which has never been approved for use before.
However, it has been around for years and tested in humans for at least four infectious diseases: rabies, influenza, cytomegalovirus, and Zika.
Dr Raine told the Commons Science and Technology Committee today that careful plans had been made for “real-time vigilance” when monitoring side effects from vaccinations.
Any updates to advice for patients would be communicated “immediately”.
She said: “The role is before, during and after, and there is a true end-to-end looking from the scientific laboratory bench through to the patient who yesterday first received the vaccine.
“As an illustration to this, I may share with the committee that even last evening we were looking at two case reports of allergic reaction.
“We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice now that we have had this experience in the vulnerable populations … we will get that advice to the field immediately.”
Professor Chris Whitty, chief medical officer for England, said the NHS and the Medicines and Healthcare products Regulatory Agency (MHRA) are in a “very good position” to pick up issues with any vaccine.
“Dr (June) Raine talked about identifying things once a vaccine is in use,” he told the Commons Science and Technology and Health and Social Care committees.
“The initial process, very importantly, picks up common side effects, that’s what the big phase two and then subsequently, if they are safe, phase three clinical trials allow to happen.
“But extremely rare but important issues, inevitably you accrue more information over time.
“The NHS through to the MHRA is in a very good position to make sure that we can pick things up quickly, identifying them, communicate them widely, ensure that we improve practice.”
LANDMARK DAY
Yesterday was dubbed V-Day as the first people in the world were given the Covid vaccine in a massive step towards demolishing the disease.
Margaret Keenan, 90, was given the first jab in Coventry just after 6.30am marking the start of a phased NHS rollout of the vaccine to older people, health staff and care home workers.
GPs are now due to start booking Covid vaccine appointments within days with the UK readying itself for the arrival one million more jabs.
Two more consignments of the vaccine will be delivered both next week and the following week - on top of the initial 800,000 doses.
This means the NHS should now have four million doses of the jab before Christmas.
Boris Johnson said people objecting to having the jab are “totally wrong” to do so, amid fears anti-vaxxing campaigns will deter people from accepting an offer to receive the vaccine.
Speaking at the vaccination centre at Guy’s Hospital in London on Tuesday, the PM said it was moving to talk to Lyn Wheeler, 81, who was the first to receive the vaccine there.
The PM said: “To all those who are scared (of getting vaccinated) – don’t be. You have seen Lyn (Wheeler) take it, you have seen people take the vaccine this morning in large numbers.
“There’s nothing to be nervous about.”
He added: “What I would say is that there are those obviously who feel that a vaccine is something they object to politically or for ideological reasons.
“I think they are totally wrong. It’s safe, it’s the right thing to do, it’s good for you and it’s good for the whole country."
Prothena (NASDAQ:PRTA)reports 9-month results from long-term extension portion of the Phase 1 study evaluating PRX004, an anti-amyloid immunotherapy for ATTR amyloidosis, a rare inherited disorder characterized by the buildup of amyloid protein in tissues and organs.
Results included slowing of neuropathy progression for all seven evaluable patients, evidenced by a +1.29 point mean change in neuropathy impairment score, was more favorable than expected progression of +9.2 points in untreated and placebo-treated patients. 3 of 7 patients demonstrated improvement with a mean change in score of –3.33 points at 9 months.
PRX004 also demonstrated improvement in cardiac systolic function for all 7 evaluable patients, with a mean change in GLS, a sensitive marker that can detect subtle myocardial dysfunction, of –1.21% at 9 months.
