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Multiple COVID-19 Vaccines Could Be Ready by Fall




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Barring major setbacks, multiple Covid-19 vaccines could be ready as early as by fall. The Centers for Disease Control and Prevention thinks at least two vaccines are good to go by then. Last week, the CDC sent word to state officials on several possible scenarios. This includes where small stocks are available by October and more doses by the year-end. The vaccines were not named, but instructions match those from Pfizer and Moderna.

RELATED: Russian Coronavirus Vaccine is Ready

Given the severity of the pandemic, a single company won’t be able to make enough vaccines. This is why the US government signed contracts with many pharmaceutical companies. Each pharma needs to supply the US at least 100 million vaccines as soon as they become available. 

This means that the race to develop a vaccine is not contingent on a single winner. Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases dismisses the notion that it’s a contest. In an interview, he said: “I think the general public maybe has the wrong impression that there will be a winner and only one winner and everybody else will be a loser. That’s not the case at all. I think it’s quite conceivable, if not likely, that you’re going to have multiple candidates that’ll get over the finish line that will be good enough to be approved for production and use.”

Meet The Candidates

At present, there are a couple of candidates already in late-stage trials. This includes two vaccines undergoing late-stage trials: Moderna and Pfizer/BioNTech. The third one from AstraZeneca and Oxford University is also undergoing large-scale trials. It had to pause trials earlier this week as a British subject developed an illness.

Despite the setback, AstraZeneca is confident it will roll out COVID-19 vaccines within 2020. CEO Pascal Soriot said that he expects data from the trials will support approval by year-end. He told reporters that “We could still have a vaccine by the end of this year, early next year.” The safety review due to the illness is a normal occurrence in large trials. This helps check if the illness is because of the vaccine, or is coincidental.

Two other companies that are in the running are Novavax and Johnson & Johnson. Both are about to start their large scale trials this September, in time for a Dec or early 2021 release. Vaccines from China and Russia also are in late-stage testing and are showing promise as well.

Limited Supplies At First

If ever the timetable proves true, not everybody will get vaccines immediately.  Even as the US locked up pre-orders, limited supplies are foreseen at first. Experts estimate 10-15 million doses will arrive at first.

The National Academy of Medicine proposes rolling out the vaccine by phases. Frontline health workers and essential personnel will get to have the first doses. The next phase would vaccinate high-risk patients, seniors, and essential workers. Only after these groups will the program reach the general population.

Having different companies could also mean different segments can receive different vaccines. Different vaccine types can address groups that are more sensitive to side effects. Children and the elderly may need vaccines that are less potent than regular ones. Some types may prevent infections, while others can reduce the severity of symptoms.

COVID-19 Vaccines Possibilities

Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor, believes it’s possible to have many vaccines by 2021. He expects “different vaccines of different degrees of effectiveness and different degrees of effectiveness in a range of populations.”

By now, the Covid-19 pandemic has already caused a lot of stress among families and economies. Approval for an effective vaccine holds the best chance for things to normalize. Even if a candidate gets the green light, it will take some time before a dose reaches the average American. Until then, all we can do is remain prudent and safe.

Watch this as CNBC talks to Dr. Anthony Fauci of the CDC on the possibility that COVID-19 vaccines approval might come by end of the year:

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Trump Wants To Fast Track COVID-19 Treatment




COVID-19 Treatment

President Donald Trump wants to make sure that a COVID-19 treatment is available ASAP. If there’s something available before the elections, he wants them available. On separate occasions last week, the President signaled that the fight against COVID-19 is winnable. And more important, that the answers might come sooner than later. 

RELATED: Moderna Coronavirus Vaccine Trial Proclaims Success

Trump: “Focus on speed and saving lives!”

On Saturday, Trump fired shots at the Food and Drug Administration over the slow pace of approvals. He tweeted: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.” Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” 

In response, the FDA gave an emergency use authorization (EUA) for a COVID-19 treatment the next day. This involved the use of plasma taken from patients who recovered from COVID-19. While promising, the FDA still maintains that the treatment only benefits some patients. The agency advised that the public should not look at plasma “as a new standard of care for the treatment.” The EUA will broaden the use of a treatment already used in more than 70,000 patients. Unlike drugs, plasma is not manufactured but depends on blood donations. This may present difficulty in getting the needed amount to help.

President begged to differ from the FDA. He said that the approval marked “a breakthrough” in the treatment of the coronavirus. Trump noted the approval came “by marshaling the full power of the federal government.” The treatment, he said, is welcome news in the fight against coronavirus. 

By August, COVID-19 has infected more than 5 million Americans and has caused the deaths of 176,000 more. At present, the United States holds about 25% of all coronavirus cases in the world.

“A Major Advance in Treatment”

US Health and Human Services Secretary Alex Azar said studies justified the EUA. During a White House briefing, Azar discussed a previous study with 70,000 volunteers. He said that “The data we gathered suggests that patients who were treated early in their disease course, within three days of being diagnosed, with plasma containing high levels of antibodies, benefited the most from treatment. We saw about a 35% better survival in the patients who benefited most from the treatment.” He added: “We dream in drug development of something like a 35% mortality reduction. This is a major advance in the treatment of patients. A major advance.” 

Potential Fast Track for the Covid-19 Vaccine

Meanwhile, the President is also looking at fast-tracking a potential coronavirus vaccine. The Financial Times reported that the White House is looking at a EUA for a British vaccine. The vaccine under consideration is co-developed by AstraZeneca and Oxford University. It is now undergoing large scale Phase II/III trials, including 30,000 Americans. Using a regular timetable, AstraZeneca expects results until the end of the year. If the EUA happens, this can make a vaccine ready for Americans before the November elections. 

The market was quick to pick up on the information. Stock prices of AstraZeneca (AZN), rose more than 2% on Monday. A company spokesperson denied there are ongoing talks with the federal government. He said, “it would be premature to speculate.” 

Even without the EUA, the US will be among the first countries to receive an approved vaccine. The federal government gave over $1 billion to help fund AstraZeneca’s efforts. In return, the US will receive 300 doses of the vaccine as soon as it becomes available.

Not Just A Vaccine, But Maybe a Cure

Vaccines may be in the spotlight, but other Covid-19 treatments are under consideration. With millions infected at present, developing a cure can help turn the tide against Covid-19.  

AstraZeneca also started testing its new antibody-based drug to prevent and treat Covid-19. This is a separate effort from its vaccine development program as mentioned above. If the tests show that the drug AZD7442 is safe, they will proceed to a larger trial phase. The company will test if it works both as a medicine to cure Covid-19 and as a preventative treatment.

Watch this as the U.S. FDA authorizes blood plasma for COVID-19 treatment:

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Coronavirus Relief Talks




Coronavirus Relief Talks

House Speaker Nancy Pelosi (D – CA) and the Democrats have walked off the negotiation table. She said that coronavirus relief talks are dead unless the GOP agrees to a $2 trillion budget. In her weekly news conference, Pelosi said she doesn’t know when talks will resume. She said: “I don’t know when they come with $2 trillion. When they’re ready to do that, we’ll sit down.” Asked why she thinks the GOP won’t budge, she said she mistook them for “someone who gave a damn.” 

Pelosi: No $2 Trillion Budget, No Coronavirus Relief Talks

The deadlock in the latest coronavirus relief package stems from the budget. Democrats want a $3.4 trillion package, while Republicans preferred a $1 trillion cap. Pelosi offered to decrease their proposal to $2T if the GOP would raise their budget to the same amount. 

RELATED: Trump’s Four Executive Orders for Coronavirus

Talks further broke down between more disagreements in other areas. Both sides have not agreed on the amount for the second round of stimulus checks for Americans. The matter of unemployment aid remains unresolved. Equally open-ended were stated calls for more funds, as well as budgets for reopening schools.

White House Firm 

The White House is firm in the $1 trillion camps. Treasury Secretary Steve Mnuchin called the $2 trillion price tag “a non-starter.” He said that the additional $1 trillion for state and local governments is absurd. He added that states and cities already have plenty of cash. White House economic adviser Larry Kudlow remarked talks are at a “stalemate.” He said that “the Speaker wants a $2 trillion commitment from us. We’re not going to give it. Kudlow added that Democrats have “too many tasks on their side that…don’t have anything to do with COVID…” 

By Thursday, the Senate adjourned with no progress in the talks. Senate Majority Leader Mitch McConnell (R-Ky.) kept the chamber in session this week, despite the fact the Senate was already in recess. This week’s session was a last-ditch effort to get an agreement. Without any fresh developments, Senators proceeded with their recess. They followed House members who already left town and aren’t expected to return until Sept. 14.

McConnell accused Democrats of negotiating in bad faith. He noted that Democrats hold an agreement “hostage” while they pretend to negotiate. The senator warned that “voters are watching,” and the country knows what he’s talking about. “I’m talking about the absurd issues which the Democrats have turned into sticking points,” he said.  

Executive Orders

Without any deals, President Donald Trump’s executive orders appear as the only action. Sen. Chuck Grassley (R-IA) said that only Trump’s orders would be available by September. He said that “this is all you’re going to see until Congress gets back into session after Labor Day.” Trump issued a series of orders earlier this week aimed to provide Americans with relief. These include the resumption of the unemployment insurance, which expired last July 31. Reduced from $600 to $400, the financial aid would be borne by both federal and state governments 75%-25%. The President also ordered the temporary suspension of the payroll tax. Moratoriums were also requested for student loan payments and evictions from rented homes. 

The orders will face some legal challenges when implemented. Congress controls the purse for any new projects and approves any budget diversions. If ever, the President will shrug his shoulders and say that at least he did something. He is almost daring opponents to stop his orders and deprive Americans of help. Trump remarked: “If we get sued, it’s [from] somebody that doesn’t want people to get money. And that’s not going to be a very popular thing.” 

With time running out for a new deal, Americans are getting angrier by the minute. Coronavirus outbreaks are still happening, but promised relief packages are nowhere in sight. Both parties seem OK to suspend talks out of their principles. But it’s American folk who suffer in the meantime.  

In the end, President Trump may get the last laugh out of this. His orders may have some legal issues, but with Congress acting like brats, his plan may be the only relief on the table. The more Dems and Republicans butt heads over the budget, the more popular Trump’s orders will be. Come November, you’ll be hearing a lot of people saying “at least he did something.”

Watch this as Pelosi discusses latest coronavirus relief negotiations:

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Russian Coronavirus Vaccine is Ready




Russian Coronavirus Vaccine

Russian President Vladimir Putin announced, “regulatory approval” for the world’s first coronavirus vaccine. He announced that the country will begin mass production by September.

Putin Announces Russian Vaccine for Coronavirus Is Ready

However, the news faced doubts and concerns in the global community. Experts believed testing did not reach phase 3 and was only administered to dozens. Aside from Putin’s statement, Russian authorities have yet to show further proof. He said: “I know it has proven efficient and forms a stable immunity. We must be grateful to those who made that first step very important for our country and the entire world.” Putin also disclosed that one of his daughters received a vaccine and that she felt fine after. 

RELATED: Multiple COVID-19 Vaccines Could Be Ready by Fall

The Russian timetable for deployment is now tight. Reuters said that mass trials for Gamaleya will start only after regulatory approval. This stage will involve the required thousands of participants. Deputy Prime Minister Tatyana Golikova said the first group receiving vaccines are doctors. Medical professionals will receive the first vaccines by August and will be monitored. Meanwhile, large-scale production starts in September. If everything goes well, mass vaccination may begin by October.

Concerns over safety, speed

Russia appeared to beat frontrunners in coming up with a ready vaccine. Moderna Inc, Pfizer/BioNTech, and AstraZeneca/Oxford University are in advanced testing phases for their candidates. Some governments have pre-purchased stocks from these firms in anticipation. These include the United States, the United Kingdom, India, Brazil, and Japan. 

Experts worldwide have raised questions about the Russian vaccine, named Gamaleya. They have raised the concern that it did not undergo phase 3 trials, which ensures the safety of the drug. Reports of Russian scientists injecting themselves with the vaccine circulated last July. While this move sped up development, it did not follow protocol. Russia’s Association of Clinical Research Organizations told the media their concern about the process. Scientists who injected themselves were a “crude violation of the very foundations of clinical research, Russian law, and universally accepted international regulations.” 

Jens Spahn, German Health Minister, also shared his concerns over Russia’s vaccine. He warned that without full testing, the vaccine could turn out unsafe or ineffective. This in turn could affect further acceptance of vaccines by the public. Spahn said: “It can be dangerous to start vaccinating … people too early because it could pretty much kill the acceptance of vaccination if it goes wrong.” He added, “I’m very skeptical about what’s going on in Russia.” 

Publicity Stunt

Moscow has also decided to call the vaccine “Sputnik V.” The name alludes to its predecessor, Sputnik, which is the world’s first satellite. Like Sputnik, the vaccine touts itself as the first of its kind. 

Despite skepticism surrounding the vaccine, markets responded positively earlier in the day. Investors pounced on stocks that they think would enjoy a reopened economy. Later that day, earlier gains got overshadowed when investors started selling tech stocks. 

Dr. Derek Lowe, a blogger for Science Translational Medicine website, called the vaccine announcement as “a ridiculous publicity stunt.” He questioned the term “regulatory approval,” saying it is not an international standard. While the idea behind the vaccine makes sense, Lowe questions its development timelines. Given the requirements, he says there wasn’t enough time given for proper testing. He noted that nobody can “responsibly approve” a vaccine that has less than two months of trials. 

“Vaccine Nationalism”

Lowe warned against “vaccine nationalism,” and said it was the last thing needed right now. Using the vaccine to proclaim superiority over other countries’ efforts is counterproductive. He argues that coronavirus research needs to be as international as possible. 

If it turns out to be true, the Russian vaccine could signal the beginning of the end for the coronavirus issue. The world needs all the help it can get to finally control the outbreak and regain some sense of normalcy. But that is a big “if” as questions about its safety and efficacy surround its development. 

The bigger issue will be the PR problem the Russian vaccine will create once it’s out in the market. If it works, why are we still waiting for our vaccines? If it goes bad, we should think of another solution other than vaccines. In the meantime, dealing with coronavirus should be like handling your business. Until you have the vaccine, you don’t have it. Act accordingly.

Watch this as Russia Approves Coronavirus Vaccine:

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