Over 92 million COVID-19 vaccine doses have been administered across the United States as of Monday, according to the latest data from the Centers for Disease Control and Prevention.

There are currently three vaccines approved by the CDC and the Food and Drug Administration for emergency use, which were manufactured by Pfizer and BioNTech, Moderna, and Johnson & Johnson.

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Here’s a FOX Business roundup of the profit each company’s vaccine is expected to bring in:

Pfizer and BioNTech
Pfizer and BioNTech’s Comirnaty vaccine, the first to receive an emergency use authorization from the FDA in December after it was found to be 95% effective, currently accounts for more than 46.8 million of the total vaccine doses administered in the United States, according to the CDC.

Pfizer’s latest earnings report notes that Comirnaty profits are split 50-50 with BioNTech. The companies expect the vaccine to bring in revenues of approximately $15 billion in 2021. Pfizer and BioNTech plan to supply up to 1.3 billion doses of the vaccine worldwide by the end of 2021. The vaccine, which requires two doses, costs $39 in the United States and £28 in the EU.

Following Comirnaty’s approval, the United States agreed to pay the companies $1.95 billion upon the receipt of the first 100 million doses. The agreement also allowed the federal government to purchase an additional 50 million doses. Later that month, Pfizer, BioNTech and the federal government reached a second agreement for 100 million more doses for the same $1.95 billion price tag. Under the second agreement, the companies will deliver at least 70 million of the additional doses by June 30, with the remaining 30 million doses to be delivered no later than July 31. The government also has the option to acquire up to an additional 400 million doses.

Pfizer and BioNTech also announced an agreement in November with the European Commission for 200 million doses of the vaccine to be distributed to the European Union’s 27 member countries, with the option to request an additional 100 million doses. The European Comission made that request in December, Pfizer said.

Last month, Pfizer said the European Commission had reached a second agreement for an additional 200 million doses, 75 million of which will be supplied in the second quarter of 2021. The total number of doses to be delivered to the E.U. member states by the end of 2021 is now 500 million, with the potential to increase to 600 million based on the option granted in the new agreement.

Moderna
Moderna’s mRNA-1273 vaccine, the second to be approved for emergency use by the FDA after it was found to be 94.5% effective, accounts for more than 44.9 million of the total vaccine doses administered in the United States, according to the CDC.

The company noted in its fourth quarter earnings report that it expects $18.4 billion in anticipated product sales related to advanced purchased agreements for its vaccine. Moderna remains on track to deliver the first 100 million doses in the first quarter of 2021 and the second order of 100 million doses in May 2021. The company is aiming to build supply up to 1 billion doses in 2021, and 1.4 billion doses in 2022.

Moderna has reached an agreement with the United States for 300 million doses, with the option to purchase an additional 200 million doses. In addition, the company reached agreements with the European Union (310 million doses with option to purchase an additional 150 million doses in 2022), Japan (50 million doses), Canada (44 million doses), the Republic of Korea (40 million doses), the United Kingdom (17 million doses), Switzerland (13.5 million doses), Colombia (10 million doses), Israel (6 million doses) and Taiwan (5 million doses).

Moderna charges $30 for the required two shots in the U.S. and $36 in the E.U.

Johnson & Johnson
Johnson & Johnson’s vaccine, manufactured by its pharmaceutical subsidiary Janssen, was given an emergency use authorization by the FDA on Feb. 27 and an official stamp of approval from the CDC a day later.

According to an analysis by the FDA, the Janssen vaccine was about 67% effective in preventing moderate to severe cases within 14 days after dosing and 66% effective against severe to critical cases after 28 days. In addition, the vaccine was approximately 77% effective in preventing severe or critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe or critical COVID-19 occurring at least 28 days after vaccination.

The company is currently working to deliver its initial supply of 3.9 million vaccine doses to state health departments, pharmacies, federally qualified health centers and community vaccination centers across the country. Johnson & Johnson expects to deliver enough single-shot vaccines by the end of March to vaccinate more than 20 million Americans, and 100 million single-shot vaccines by June. Unlike the other two available vaccines, the Janssen vaccine requires a single dose.

The company is on track to produce 1 billion doses for global distribution by the end of 2021, which would generate up to $10 billion. In August, Johnson & Johnson reached a more than $1 billion agreement with the United States for 100 million doses of its vaccine, with the option to purchase an additional 200 million doses, for $10 per shot. In addition, Johnson & Johnson reached an agreement with the E.U. for up to 400 million doses.

According to Johns Hopkins University, the United States has surpassed 29 million COVID-19 cases since the pandemic began in March 2020, with over 525,000 related deaths.

Source: https://www.foxbusiness.com/money/heres-how-much-money-pfizer-moderna-and-johnson-johnson-could-make-from-covid-vaccines

The post Here’s how much money Pfizer, Moderna and Johnson & Johnson could make from COVID vaccines first appeared on Garner Ted Armstrong Evangelistic Association.

The Food and Drug Administration on Friday approved requests by COVID-19 vaccine makers Moderna and Pfizer to expand the administration of their booster shots to all U.S. adults.

In a release announcing the news, biotechnology company Moderna said the FDA extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older.

The booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” Moderna CEO Stéphane Bancel said in a statement. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”

Pfizer, which partnered with BioNTech on the vaccine, said its booster dose is to be administered at least six months after completion of the primary series and is the same dosage strength as the doses in the primary series.

“With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease,” Pfizer CEO Albert Bourla said in a statement. “We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic.”

“Today’s FDA decision is supported by clinical data showing robust immune responses following a booster dose of our vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule,” BioNTech CEO Ugur Sahin said. “These data suggest a booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”

Later Friday, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the rollout of COVID-19 boosters to the U.S.

CDC data shows that more than 32 million Americans have already received a booster dose.

Source: https://www.foxbusiness.com/lifestyle/moderna-pfizer-covid-boosters-approved

The post FDA clears Moderna, Pfizer COVID-19 boosters for all US adults first appeared on Garner Ted Armstrong Evangelistic Association.

BEIJING (BLOOMBERG) – China has urged local authorities to halt compulsory coronavirus vaccinations as the central government tries to balance the urgency of its inoculation efforts and possible backlash from a hesitant population.

“Some areas are making the vaccination rather simplified, and even mandatory for everyone. This approach must be corrected,” a spokesperson for the National Health Commission said at a Sunday (April 11) briefing.

The directive appears to be aimed at curbing the heavy-handed tactics of some local authorities to ramp up vaccinations after the government set a target of vaccinating 40 percent of the population, or some 560 million people, by the end of June.

In one example, Wanning, a city in the southern province of Hainan, warned residents could be blacklisted from receiving government benefits or using public transport if they failed to get vaccinated.

China will adhere to the guideline that people get vaccinated voluntarily, according to Mr. Wu Liangyou, a senior official at the National Health Commission.

While China has mostly quashed the coronavirus, it is facing hurdles in its vaccination drive as people don’t see the same urgent need to get inoculated as those in countries still battling COVID-19.

In order to catch up with western rivals like the US, China has been calling on the tens of millions of people who work at state-owned enterprises, and the roughly 90 million Communist Party members, to act as role models in the push.

The country has administered 164.5 million doses so far, while the US has delivered 187 million, according to Bloomberg’s Vaccine Tracker.

The vaccine rollout is facing other challenges, including a supply shortage as the acceleration pushes the limits of domestic vaccine makers.

Uncertainty is also growing over whether the lower protection rate conferred by Chinese shots, compared to mRNA ones by Pfizer Inc and Moderna Inc, will hurt the country’s race towards herd immunity.

The post China calls for halt to mandatory Covid-19 vaccinations amid inoculation push first appeared on Garner Ted Armstrong Evangelistic Association.

AstraZeneca’s COVID vaccine (pictured) is one of the first to receive authorization in the U.K. A number of exciting vaccines are still in the pipeline. Credit: Russell Cheyne Getty Images

Six months ago, as the northern hemisphere was still battling the coronavirus pandemic’s first wave, all eyes turned to the COVID-19 vaccines in late-stage clinical trials. Now, a year after the pandemic first erupted, three COVID vaccines have been given emergency authorization by either the U.S. or U.K., as well as other countries. Two of the vaccines, developed by Pfizer and BioNTech and Moderna, respectively, both employ a novel genetic technology known as mRNA. And the third is a more conventional vaccine developed by the University of Oxford and AstraZeneca that uses a chimpanzee virus to deliver DNA for a component of SARS-CoV-2, the virus that causes COVID. (Russia, China, and India have rolled out their own vaccines, but with the exception of a few countries, they have not been widely authorized elsewhere.)

But impressive as they are, these vaccines alone will likely not be sufficient to end the pandemic, experts say. Luckily, there are hundreds of other COVID vaccines under development—including many with new mechanisms of action—that could prove to be effective and cheaper, and easier to distribute.

“I believe that this virus is going to change and that the vaccines we have approved right now are just not going to be as effective as we think they are,” says Danny Altmann, an immunologist at Imperial College London. SARS-CoV-2 has already evolved several new variants—including the ones first identified in the U.K. and South Africa, which are more transmissible (though not—for now, at least—more deadly).

Gregory Poland, a vaccinologist at the Mayo Clinic, agrees it is far too early to think we have this virus beat. He points out that no vaccine for a coronavirus has ever been deployed in a public vaccination program. And mRNA vaccines such as Pfizer’s and Moderna’s—touted by many as the future of vaccinology—have never previously been brought to market. “We don’t know what we don’t know. We have no idea what surprises we might find in a virus that we’ve only been aware of for a year,” says Poland, who co-authored an extensive review of COVID-19 vaccine candidates in the Lancet last October. “And the history of vaccinology—in which I’ve been involved for four decades—is amply littered with things we thought we knew.”

What happens if somebody is vaccinated but contracts COVID anyway? Would they suffer an even worse case of illness, a phenomenon known as antibody-dependent enhancement? Or in a less dramatic scenario, what if the vaccines prevent immunized individuals from falling ill but do not prevent them from infecting others? The latter could actually worsen the pandemic if vaccinated individuals think they are safe and become asymptomatic carriers. Moreover, people worldwide display a wide range of natural immunity to the virus, so there may be a similar diversity in vaccine responses. “There are lots of booby traps that could lie in wait,” Poland says.

Furthermore, the vaccines from Moderna and Pfizer have logistical issues that prevent them from being easily deployed globally. Pfizer’s vaccine needs to be stored at –70 degrees Celsius—colder than Antarctica’s average temperatures—in freezers that cost many thousands of dollars. Moderna’s can be stored at –15 degrees C, but because of freezer requirements, it still has little chance of reaching rural corners of India or Africa or poor, densely packed neighborhoods in South America. As long as vaccines are fragile, expensive and difficult to distribute, the pandemic will continue.

But by far the most important issue, Altmann says, is “durability”: how long people remain immune after vaccination. If a vaccine confers immunity for only a few months rather than many years, little progress will have been made in six months. By then we could be faced with more virulent forms of the disease swirling around the globe.

The good news, however, is that “second generation” vaccines are being developed by researchers, many of whom are working with novel techniques. “We have an embarrassment of riches,” Altmann says. “One thing that certainly hasn’t been appreciated by most people is that, on the back burner, the field of vaccinology has been steaming ahead over the past 15 years, developing a range of incredibly snazzy strategies.”

There are nearly 240 novel vaccine candidates in development, waiting in the wings for their moment. Here are a few that show the most potential.

SELF-AMPLIFYING RNA (IMPERIAL COLLEGE LONDON)

Similar to the approved mRNA vaccines, this one inserts genetic material from the virus directly into human cells, spurring the body to manufacture the famed “spike” protein that covers the surface of SARS-CoV-2. And like mRNA vaccines, Imperial College London’s design only delivers the genetic material, not the actual virus, so it is unlikely to exacerbate illness if people are infected following vaccination. The twist with this vaccine is that it has been modified to turn the body’s own cells into factories that continually churn out spike proteins on their own—meaning a booster shot will not be necessary. Moreover, such “self-amplifying” RNA can reportedly be made in huge volumes for little cost. “I feel very excited about the way [this approach] may turn out to be like Pfizer’s and Moderna’s vaccines but even better,” says Altmann, who was not directly involved in developing this vaccine.

PROTEIN SUBUNIT (NOVAVAX)

Researchers at the Maryland-based start-up Novavax have focused on delivering the actual spike protein itself (rather than a whole virus or genetic material). They created the vaccine by engineering moth cells to churn out spike proteins in bioreactors at low cost. Furthermore, this vaccine can be kept at two to eight degrees C—normal refrigeration temperature—making it far more practical to distribute. The trick with this approach is the addition of an “adjuvant”—an additive that “soups up” the immune system’s response—made from saponin, a compound derived from the bark of the Chilean soapbark tree. “Engineered protein technology has been tested and proved in the past—it just takes a little more time to produce than RNA,” explains Gregory Glenn, president of research and development at Novavax.

DESIGNED PROTEIN NANOPARTICLE (INSTITUTE FOR PROTEIN DESIGN, UNIVERSITY OF WASHINGTON)

Like Novavax, University of Washington researchers have chosen to deliver proteins from SARS-CoV-2 as their weapon of choice. But instead of injecting the entire spike protein, they have homed in on the virus’s “Achilles’ heel”: the receptor binding domain (RBD), the portion of the spike protein that directly fuses with human cells. Neil King, a biochemist at the university’s Institute for Protein Design, has created a vaccine delivered by spherical “nanoparticles” shaped like soccer balls. Synthetically manufactured RBD proteins are affixed to the nanoparticles in regular arrays. This design makes the vaccine capable of eliciting antibody responses at least 10 times higher than those that use the whole, natural spike protein, King says. “We aren’t just taking existing proteins and tweaking them a little bit—we are making completely new ones to do exactly what we want,” he notes. The vaccine is currently being tested in early-stage, or phase I, trials with human volunteers. If successful, it could reach the public later this year.

OTHER VACCINES IN THE PIPELINE

These are just a few of the vaccine candidates in development. Others that could help slow the pandemic, including the vaccine developed by Sinovac Biotech in China, utilize more conventional designs, such as an inactivated virus (a technique used to help conquer polio and still used in many influenza vaccines). It remains to be seen how well all of these approaches may work. But with so many efforts underway, there is good reason to hope that the end of this pandemic nightmare is in sight.

And when it does end, scientists will have many tools ready-made for when the next pandemic hits.

Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here.

Source: https://www.scientificamerican.com/article/the-second-generation-covid-vaccines-are-coming/

The post The Second-Generation COVID Vaccines Are Coming first appeared on Garner Ted Armstrong Evangelistic Association.