Will I Need A Johnson & Johnson Vaccine Booster Shot
On Wednesday, Johnson & Johnson said a booster shot of its COVID-19 vaccine increases antibody responses in those who received the company’s one-dose vaccine, based on interim data from an early trial. The company said it would work with public health officials on a plan for a booster shot for eight months or longer after the first dose of its vaccine.
Currently, the one-dose Johnson & Johnson vaccine is available under an emergency use authorization for individuals 18 years of age and older.
Biden administration health officials said they expect those who received the one-dose Johnson & Johnson vaccine will need another jab, but more research is necessary. “We expect more data on J&J in the coming weeks,” Murthy said when announcing plans for booster shots. “With that data in hand, we will keep the public informed with the timely plan for J&J booster shots.”
The Immune Systemthe Bodys Defense Against Infection
To understand how COVID-19 vaccines work, it helps to first look at how our bodies fight illness. When germs, such as the virus that causes COVID-19, invade our bodies, they attack and multiply. This invasion, called an infection, is what causes illness. Our immune system uses several tools to fight infection. Blood contains red cells, which carry oxygen to tissues and organs, and white or immune cells, which fight infection. Different types of white blood cells fight infection in different ways:
- Macrophages are white blood cells that swallow up and digest germs and dead or dying cells. The macrophages leave behind parts of the invading germs, called antigens. The body identifies antigens as dangerous and stimulates antibodies to attack them.
- B-lymphocytes are defensive white blood cells. They produce antibodies that attack the pieces of the virus left behind by the macrophages.
- T-lymphocytes are another type of defensive white blood cell. They attack cells in the body that have already been infected.
The first time a person is infected with the virus that causes COVID-19, it can take several days or weeks for their body to make and use all the germ-fighting tools needed to get over the infection. After the infection, the persons immune system remembers what it learned about how to protect the body against that disease.
This Thai Robot Can Squeeze More Doses Out Of Vials To Make Covid Vaccines Go Further
As Thailand struggles with its worst coronavirus outbreak yet, researchers in the country have developed a machine to draw out COVID-19 vaccine doses more efficiently and optimise lower-than-expected supplies.
Using a robotic arm, the “AutoVacc” system can draw 12 doses of the Oxford/AstraZeneca vaccine in four minutes from a vial, according to researchers at Chulalongkorn University, who made the machine that has been used at the university’s vaccination centre since Monday.
That is up 20 per cent from the standard 10 doses drawn manually, they said. The machine only works on AstraZeneca multi-dose vials currently and labels show each vial can provide 10 to 11 doses.
“The machine guarantees with accuracy that we can gain an extra 20 per cent from each vaccine vial – from 10 to 12 doses,” said Juthamas Ratanavaraporn, the lead researcher of the team at the university’s Biomedical Engineering Research Center.
“The extra 20 per cent that we get means that if we have AstraZeneca for 1 million people, this machine can increase the number of doses to 1.2 million people,” said Juthamas.
While some health workers using low dead space syringes that aim to reduce wastage can draw up to 12 doses per vial, it requires manpower and a high level of skill, she said.
People With Underlying Medical Conditions Included In The Covid
Vaccine manufacturers report information from clinical trials, including demographics and underlying medical conditions of people who participated in COVID-19 vaccine trials. You can find additional information on COVID-19 vaccine clinical trials at clinicaltrials.govexternal icon, a database of privately and publicly funded clinical studies conducted around the world.
Find a COVID-19 Vaccine: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 to find locations near you.
Pfizer In The Driver’s Seat
Although all the Operation Warp Speed agreements with vaccine makers were a little different, Pfizer’s stands out. As part of its eventual federal deal, Pfizer got a tailor-made contract awarded through Advanced Technology International.
In exchange for doing its research and development without government help, Pfizer got a contract that let it retain almost all of its intellectual property rights and forgo the taxpayer protection clauses found in most government contracts that fund inventions.
There were incremental targets in Pfizer’s original Operation Warp Speed contract to deliver 20 million doses a month starting in November and ending in March to hit 100 million eventually in all. But the contract said those requirements were “subject to change” based on a variety of factors outside the company’s control.
“They’re not hard and fast deadlines,” said Kathryn Ardizzone, a lawyer at Knowledge Ecology International who reviewed the vaccine contracts. Knowledge Ecology International is a nonprofit public interest group focused on intellectual property.
The contract doesn’t specifically give the government the right to verify Pfizer’s reasons for not meeting a delivery milestone. That’s apparent in the way the contract lays out how vaccines beyond the original 100 million doses would be purchased, Ardizzone said. It just said Pfizer “shall inform the government” how many additional vaccine doses it can make and on what timetable.
Thoughts On Employers Who Mandate Covid Vaccines May Be Held Liable For Any Adverse Reaction
I hope they nail any bastards to the wall that push this to a familys detriment. And even more so should it damage womens fertility, as Ive heard it can. Imagine losing out on children because of this mess.
Great post, thank you. Indeed. If its required you have to fight hard with facts/data etc to back up your reasoning for refusing.
Yeah,,The NFL is the perfect litmus test for whether this is a Pandemic or the Flu or just a scam or ect ect ect,.Over 10,000 employees and MANY covid positive tests,.Most ARE vaccinated and MOST have no symptoms? And ZERO fatalities or even severe sicknesses,.So 10,000 people who are constantly and closely monitored and,..?Anyone?
Question are governors liable for COVID vaccine mandates If so please state law or reference. Im hoping they are liable
The FDA is not liable UNLESS it changes its protocols for deeming a drug or vaccine SAFE,.Of course Im sure when they FDA approve any of these vaccines that they will try to make a law against them being sued
University of Miami is also mandating vaccines to all employees even employees that are 100% remote. This makes no sense.
”big Ginormous Assumption” On Manufacturing Success
When then-President Donald Trump announced his administration’s COVID-19 vaccine initiative in the Rose Garden on May 15, 2020, he said: “It’s called Operation Warp Speed. That means big, and it means fast.”
He was right. Vaccine development usually takes years. But by spending billions of dollars right away, the Trump administration was trying to condense that timeline to less than a year. A big chunk of the money was earmarked to help companies gear up their manufacturing so they could begin making vaccines even before they knew for sure if they worked.
Moncef Slaoui, the former GlaxoSmithKline executive who had been tapped to be the scientific lead of Operation Warp Speed, paused to address Trump directly during the press conference.
“In fact, Mr. President, I have very recently seen early data from a clinical trial with a coronavirus vaccine. And this data made me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020.”
But the reality, said pharmaceutical manufacturing consultant John Avellanet, is that there was no way these companies could ever have delivered that many doses before the end of the year. “That was a fantasy,” he said.
Manufacturers can expect to face unforeseen hurdles when they begin to mass-produce a brand new vaccine. And in a pandemic, there are bound to be supply chain problems as well.
Lost Record Of Immunization
If you have a copy of your record of immunization, you can book at either a clinic held by VitalitÃ© or Horizon health networks or at a Pharmacy.
- If you have lost your Record of Immunization and got your first dose at a New Brunswick Pharmacy, you can book an appointment through either a pharmacy or a clinic hosted by a health authority.
- If you have lost your record of immunization and got your first dose at a clinic hosted by a regional health authority, you must again book through a regional health authority.
- If you got your first dose outside of New Brunswick and have lost your record of immunization, you will need to contact the jurisdiction or organization that provided the first dose to obtain a record of that dose.
Who Could Qualify For The Covid
Earlier this month, health officials in the Biden administration recommended an additional shot for Americans 18 and over who are fully vaccinated with the Pfizer or Moderna shots, proposing a booster eight months after being fully vaccinated.
On Friday, during a meeting with Israeli Prime Minister Naftali Bennett, Biden said administration health officials were evaluating a five-month gap, based in part on data from Israel’s booster program. The news followed a report by The Wall Street Journal that the Biden administration was evaluating a booster shot six months after the last jab.
Whatever the time gap, the booster plan would need to be evaluated and approved by the Food and Drug Administration, which will review the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines. The plan is also pending recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“We believe that that third dose will ultimately be needed to provide the fullest and continual extent of protection that we think people need from the virus,” Murthy said. “Our plan is to stay ahead of this virus by being prepared to offer COVID-19 booster shots to fully vaccinated adults 18 years and older.” Murthy said the FDA will evaluate booster shots for those younger than 18 years of age, and the administration will follow FDA recommendations for minors.
Euronews: What Are The Dangers For Pregnant Women And The Fetus Contracting Covid
Dr Mosina: We know that pregnant women are at higher risk of severe COVID-19 diseases than women in reproductive age who are not pregnant. We have seen multiple evidence that proves this.
Pregnant women face a higher risk of admission into intensive care units if they get COVID-19 or can be at a higher risk of invasive ventilation.
COVID-19 in pregnancy also poses a risk for babies. Pregnant women who get COVID-19 during the pregnancy have a higher risk of premature delivery and their children are at a higher risk of needing intensive care. These are facts that we know today.
Concerns Over Mrna Vaccine
According to Dr. Kenyon, misinformation surrounding mRNA vaccines stems from a concern that the vaccine infects people with the virus.
Nobody is getting infected with a COVID vaccine. It is only the surface protein that would be replicated because we have given you the messenger RNA. It is not the entire virus, he explained.
One misconception is that an mRNA vaccine would not be useful if the virus mutates.
A July study published in Frontiers in Microbiologyconfirms that the virus mutates. After analyzing 48,635 samples of SARS-CoV-2, the researchers identified an average of 7.23 mutations per sample.
A more recent study, published in November in , found that a D614G mutation in the S protein made it more infectious. However, there was no evidence to suggest a link between the mutation and more severe illness.
While mutations are possible, Dr. Sun said it should not be a cause for alarm.
There has been an estimated 250,000 variants or strains of SARS-CoV-2 sequenced in the lab. For the most part, the virus has a low mutation rate compared to the mutation rate of the influenza virus , Dr. Sun explained. The spike protein is important for the ability of the virus to infect humans cells. I think it would not mutate enough for the vaccines to be ineffective.
In addition, according to Dr. Parry, virologists are continually monitoring and examining for any significant changes from new strains of the virus.
Read More About The Spread Of Covid
It is unclear if any of those who have submitted confidential proposals to the federal government’s call-out have managed to secure the company’s IP or a partnership, or if Moderna is leading its own proposal.
Monash University’s Colin Pouton believes Moderna is Australia’s “only short-term solution” of getting mRNA COVID-19 vaccines made here quickly.
“That could be done by a few companies. It could certainly be done by CSL. It could also be done by IDT,” he said.
CSL in Melbourne is the only pharmaceutical manufacturer in Australia that is already making a COVID-19 vaccine here: AstraZeneca.
Neither CSL nor IDT would comment on the nature of their proposals.
UWA’s Archa Fox said if a Moderna manufacturing deal was secured for Australia, large-scale production could be happening within 12 to 18 months.
“Being optimistic, I would be saying 12 months from the date at which the government gives a green light and funds roll out,” Dr Fox said.
“But I think there’s others in my team that would say that two to three years is more realistic.”
Moderna did not respond to queries. The federal government also declined to comment about how far along its talks with the American pharmaceutical and biotechnology company were now.
Are Vaccines Making Covid Worse
As we noted yesterday, Dr. Robert Malone is a pioneer in the mRNA technology upon which the Moderna and Pfizer vaccines are based. As we also noted: Dr. Malone is not an anti-vaxxer. He has in fact consecrated his long career to vaccine development.
Yet, he harbors grave reservations about these particular vaccines. What is his central bogey, his primary hobgoblin? He believes the vaccines may be aiding, abetting and comforting the enemy virus. Vaccinating in the middle of a pandemic is bad science, Dr. Malone argues. It is creating an arms race with the virus.
From his recent Washington Times article, which we here quote, at a length very nearly obscene:
Its an arms race with the virus.
What then is to be done? Are you yelling for a full vaccination halt? What does the good doctor prescribe?
Even CNN has conceded that: Vaccination alone wont stop the rise of variants and in fact could push the evolution of strains that evade their protection, researchers warned.
Dr. Douglas Corrigan is a Doctor of Philosophy in Biochemistry and Molecular Biology. Here he explains from what we can discern how vaccination can play the devil with the immune system:
Might this explain the surge in cases? We do not know, of course. But it seems a plausible hypothesis. To return to Dr. Malone:
What about Dr. Fauci? Was he aware of the potential vaccination hazards?
The same National Institutes of Health has expressed this very concern:
Answer please, Dr. Fauci.
Trial And Authorization Status
Phase I trials test primarily for safety and preliminary dosing in a few dozen healthy subjects, while Phase II trials following success in Phase I evaluate immunogenicity, dose levels and adverse effects of the candidate vaccine, typically in hundreds of people. A Phase III trial consists of preliminary safety and immunogenicity testing, is typically randomized, placebo-controlled, while determining more precise, effective doses. Phase III trials typically involve more participants at multiple sites, include a control group, and test effectiveness of the vaccine to prevent the disease , while monitoring for adverse effects at the optimal dose. Definition of vaccine safety, efficacy, and clinical endpoints in a Phase III trial may vary between the trials of different companies, such as defining the degree of side effects, infection or amount of transmission, and whether the vaccine prevents moderate or severe COVID19 infection.
A clinical trial design in progress may be modified as an “adaptive design” if accumulating data in the trial provide early insights about positive or negative efficacy of the treatment. Adaptive designs within ongoing Phase IIIII clinical trials on candidate vaccines may shorten trial durations and use fewer subjects, possibly expediting decisions for early termination or success, avoiding duplication of research efforts, and enhancing coordination of design changes for the Solidarity trial across its international locations.
Whos Making Money From Covid
The Covid-19 vaccines are a huge success story but this isnt necessarily reflected in companies share prices. John Bowler, a specialist in healthcare investing, explains.
The Covid-19 vaccines are a huge success story but this isnt necessarily reflected in companies share prices. John Bowler, a specialist in healthcare investing, explains.
The distribution of Covid-19 vaccines is picking up pace globally. US President Joe Biden last month set a new target of 200 million vaccination doses to be delivered in his first 100 days in office. The original target of 100 million was achieved before his sixtieth day in office.
The speed at which drugmakers were able to discover successful vaccines, undertake the necessary clinical trials, and then bring them to market in large volumes is testament to the ingenuity and innovation within the pharmaceutical and biotechnology industries.
It shows what can be achieved when all participants – governments as well as companies – work together.
How Will Hospitals And Pharmacies Keep Vaccines Cold
Once a POU receives a thermal shipper with our vaccine, they have three options for storage:
- Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months.
- The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage.
- Refrigeration units that are commonly available in hospitals. The vaccine can be stored for five days at refrigerated 2-8°C conditions.
The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally to ensure all patients have access. Once opened, and if being used as temporary storage by a vaccination center, then it can be used for a total of 15 days with re-icing every five days.
After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8°C storage conditions for an additional five days, for a total of 20 days. Once thawed and stored under 2-8°C conditions, the vials cannot be re-frozen or stored under frozen conditions.
The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure.
If Your First Dose Was Received Outside Of New Brunswick
If you received your first dose outside of New Brunswick and have lived in New Brunswick for at least four weeks, you can register for your second dose at the same time as a person who received their first dose in New Brunswick.
If you received a dose of COVID-19 vaccine outside of New Brunswick and have not been contacted, please reach out to your local Public Health office. Contact information can be found online.
Comes Amid Election Concerns
The prime ministers mandatory vaccination comments come amid ongoing concerns about an uptick in new COVID-19 infections that federal public health officials have cautioned could be the start of a “Delta-driven” fourth wave.
In light of this, Trudeau faced repeated questions about whether he is planning to launch the country into an election campaign in the coming days or weeks, which he continued to deflect, insisting his focus is on vaccinations and “delivering for Canadians even as we move forward.”
While he was out for a campaign-style event with a candidate on Thursday at a local market, Singh continues to advocate against a summer election call.
All the sacrifices that Canadians have made could be put in jeopardy by calling an election that, by the very nature an election will require some gatherings, whether people are going into line to vote, whether people are coming together to make decisions, Singh said.
Tam said Thursday that if an election is called there will be measures in place to reduce the risk of COVID-19 transmission at in-person polling places, in addition to Elections Canada preparing for an uptick in mail-in ballots.
There are definitely ways to vote safely I think it’s great to have an option, but in-person voting can be done safely, she said.
What Was The Controversy Around Covaxin
It all began when the regulator in January said the vaccine had been approved for “restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains”.
Experts wondered how a vaccine was cleared for emergency use by millions of vulnerable people when its trials were still underway. The All India Drug Action Network at the time said that it was “baffled to understand the scientific logic” to approve “an incompletely studied vaccine”.
Both the manufacturer and drug regulator defended Covaxin, saying it was “safe and provides a robust immune response”.
Bharat Biotech said that Indian clinical trial laws allowed “accelerated” authorisation for use of drugs after the second phase of trials for “unmet medical needs of serious and life-threatening diseases in the country”.
It has promised to make available the full data for third phase of trials in July.
But Making An Mrna Vaccine Is Different
Yes, with the nucleic acid vaccines you dont have any cells. You dont need any vats to grow anything in. You use a machine, a synthesiser, to add each nucleic acid onto the next in the right sequence so that you end up with the full-length RNA sequence that encodes the spike protein.
Then you have to take that and mix it with your little lipid droplets. You mix these components together in a very controlled way so that youve produced these tiny little droplets that are at the nanometre scale, with your RNA on the inside, covered by these lipids.
And again, you have to analyse them and show that they meet a very tight specification of size and what theyre composed of and be able to prove the quality of your product.
These Healthcare Companies Have Had Plenty Of Help In Building The Manufacturing Capacity Needed To Produce Billions Of Vaccine Doses
Under normal circumstances, it would be considered highly unusual for a biotech or pharmaceutical company to start building out manufacturing capacity for a drug that hasn’t yet been approved by the U.S. Food and Drug Administration . But 2020 has been anything but “normal.” The United States government has already paid billions of dollars to healthcare companies working to develop a vaccine against the novel coronavirus, well ahead of their vaccine candidates’ approvals. The federal government has a vested interest in the development of a safe and effective vaccine given that the virus has contributed to the deaths of nearly 900,000 people worldwide and wrought trillions of dollars in economic damage.
While we don’t know for sure which vaccine candidates will be approved by the FDA, we have a very real sense of the large size of the vaccine market opportunity. But which companies are acquiring the manufacturing capacity needed to supply the world with a COVID-19 vaccine in 2021? The answers might surprise you.