Treatments for COVID-19


Created on April 12, 2020.

There are no drugs or other therapeutics approved by the US Food and Drug Administration to prevent or treat COVID-19. Current clinical management includes infection prevention and control measures and supportive care, including supplemental oxygen and mechanical ventilatory support when indicated. Interim guidelines for the medical management of COVID-19 will be provided soon by the Department of Health and Human Services COVID-19 Treatment Guidelines Panel.

 

Hydroxychloroquine and Chloroquine

Hydroxychloroquine and chloroquine are oral prescription drugs that have been used for treatment of malaria and certain inflammatory conditions. Hydroxychloroquine and chloroquine are under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19. However, the FDA issued an Emergency Use Authorization (EUA) to authorize use of chloroquine and hydroxychloroquine from the Strategic National Stockpile for treatment of hospitalized adults and adolescents (weight ≥50 kg) with COVID-19 for whom a clinical trial is not available or participation is not feasible.

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Remdesivir

Remdesivir is an investigational intravenous drug with broad antiviral activity that inhibits viral replication through premature termination of RNA transcription and has in-vitro activity against SARS-CoV-2 and in-vitro and in-vivo activity against related betacoronaviruses.

Updated May 1, 2020

Food and Drug Administration (FDA) has officially authorized the emergency use of Remdesivir in COVID-19 patients, as a treatment method.

Learn more about this development HERE.

 

Convalescent Plasma

Doctors describe infusions of plasma from recovered patients as an “ancient” treatment, given that it dates back a century or so. The idea is that surviving patients have developed antibodies that target and defeat the virus, and introducing them into sick patients will help fight the disease. This treatment is undergoing trials, though some doctors are already prescribing it after obtaining federal waivers for specific patients with COVID-19 who don’t qualify for the trials. Blood banks in the Chicago area and the Red Cross are urging recovered patients to donate their plasma for both research and treatment of individual patients.

Updated August 25, 2020

On Aug 23, 2020, the FDA issued emergency use authorization to treat hospitalized COVID-19 patients with convalescent plasma from people who have recovered from the virus. However, unlike a new drug, plasma cannot be manufactured in millions of doses; its availability is limited by blood donations.

Learn more about this development HERE



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Tocilizumab

A clinical trial assessing this drug’s effectiveness in treating COVID-19 patients is expected to get underway this month. Marketed under the brand name of Actemra, the drug is currently used to treat rheumatoid arthritis and other ailments. It works by inhibiting interleukin 6, a protein that is involved in the immune response and can cause swelling, including the type of lung inflammation seen with COVID-19.

 

Vaccines

The consensus is that an effective virus is about 12-18 months away. An Oxford University scientist said Friday that a vaccine for the novel coronavirus could be ready by September. Sarah Gilbert, a professor of vaccinology at Oxford, has been working on a vaccine with a team of researchers and could possibly develop a vaccine for public use by the fall. The group has already developed a vaccine that is ready to go into clinical trials in two weeks. Gilbert said she gives the vaccine an 80 percent chance of being successful based on evidence that she has seen.

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Moderna

Updated July 15,2020

A vaccine developed by the  biotech company, Moderna, showed a lot of promise in the Phase 2 trials. Moderna was one of the companies listed in the spreadsheet below. Back in May, they were in the midst of their Phase 2 clinical trials. The results were very positive. The early volunteers developed what are called neutralizing antibodies in their bloodstream — molecules key to blocking infection — at levels comparable to those found in people who survived COVID-19. The phase 3 trials involving about 30,000 people will begin on July 27th. If all goes well, there could be a vaccine by the end of the year.

Updated October 3, 2020

Recently, in a conference hosted by Financial Times, the CEO of Moderna, Stephane Bancel, said that November 25, 2020, would be the earliest date that the company would file for emergency use authorization (EUA) for its vaccines with the FDA. This would enable healthcare workers and the elderly to have access to its treatments. The full product approval is expected to come sometime in either late Q1 or early Q2 of 2021. Incidentally, these vaccines are meant for adults. Moderna does not plan to start trials for its pediatric vaccines until the end of the year, pending approval from regulators.

Learn more about this development: HERE and HERE

Updated February 3, 2022

On January 31, 2022, Moderna's Covid-19 vaccine, known as Spkevax, received full approval from the FDA. It is now approved for people 18 years and older. This is different from the Pfizer vaccine which is also authorized for use in individuals ages 5 to 15. There's n difference between the approved vaccine and the one previously available through emergency use authorization.

Learn more about it HERE

 

Saliva Test

Rutgers University researchers have received U.S. government clearance for a new type of saliva test to help diagnose COVID-19, a new approach that could help expand testing options. With the new saliva-based test, patients are given a plastic tube into which they spit several times. They then hand the tube back to the health care worker for laboratory processing.

The Food and Drug Administration authorized the test under its emergency powers to quickly clear new tests and therapies to fight the outbreak, the New Jersey university said Monday. The test initially will be available through hospitals and clinics affiliated with the school.

Rutgers tested the accuracy of its method by taking both saliva and swab samples from 60 patients. The results from patients’ saliva samples had a 100% match with results from the swabs.

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Ventilators Alternatives

One of the biggest concerns was the lack of ventilators available for the hospitals to treat the more serious cases. However some critical care physicians are saying that ventilators may not even be necessary for some patients. They argue that more patients could receive simpler, noninvasive respiratory support, such as the breathing masks used in sleep apnea, at least to start with and maybe for the duration of the illness. This does not mean that ventilators are not needed but just their usage could be reduced, at least for a small subset of cases. 

On the flip side, there are many patients who need ventilators who do not exhibit any respiratory complaints such as shortness of breath. This is due to the strange way that the coronavirus attacks lung cells.

 

Treatments in Development

Updated May 25, 2020.

The following are a list of companies at various stages of vaccine and treatment development.

 

Dexamethasone

Updated June 28, 2020

In the United Kingdom, a randomized, controlled clinical trial has found that An inexpensive and commonly used steroid can save the lives of people seriously ill with COVID-19. The drug, called dexamethasone, is the first shown to reduce deaths from the coronavirus. In the trial, it cut deaths by about one-third in patients who were on ventilators because of coronavirus infection.

The effect of dexamethasone was most striking among critically ill patients on ventilators. Those who were receiving oxygen therapy but were not on ventilators also saw improvement: their risk of dying was reduced by 20%. The steroid had no effect on people with less severe cases of COVID-19 — those not receiving oxygen or ventilation.

Shortly after the results were released, the UK government announced that it had immediately authorized the use of dexamethasone for patients hospitalized with COVID-19 who required oxygen, including those on ventilators. 

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Vaccines (Cont’d)

Updated July 29, 2020 

How do Vaccines Work?

On a very basic level, vaccines are like a training course for the immune system. They prepare the body to fight disease without exposing it to disease symptoms. But how exactly do they do this? Well to start, when a germ enters and attacks your body, the immune system recognizes unusual foreign shapes on the surface. Then, special cells in your body called white blood cells create antibodies that go and kill this foreign object. The main purpose of a vaccine is to  develop immunity whenever the body encounters the foreign object. This is done by taking something that looks like the virus, and teach the immune system the shape of this foreign object, so it’s ready to attack with antibodies incredibly quickly when the real virus shows up. 

Vaccines don’t work on an individual level. Instead, they protect entire populations. Once enough people have been vaccinated, and immunized, opportunities for an outbreak of the disease become so low that even people who aren't immunized benefit. Essentially, because so many people have been immunized, a bacteria or virus simply will not have enough eligible hosts to spread, and will eventually die out entirely. This idea is called “herd immunity”, and it has been proven to be successful, as it has allowed once-devastating diseases to be eliminated completely. 

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How are Vaccines Created? 

There are multiple stages that have to be gone through before a vaccine can be used. It begins with the pre-clinical trial state, where researchers work on a petri dish testing to see how their proposed idea for a vaccine reacts with the virus, or bacteria. For example, if the vaccine results in virus duplication, then a new vaccine would need to be tested. But if the vaccine is able to kill the virus on the petri dish, then researchers can move into the clinical trials stage.

The clinical trials are essentially the first steps in testing the vaccine on humans. During the phase one clinical trials, the vaccine’s safety and toxicity at different doses is evaluated by measuring the blood's response (i.e. the antibodies it forms or does not form). Additionally, phase one trials are limited to a very small number of subjects (usually between 25-50), as the safety and toxicity of the vaccine is still unknown. If phase one clinical trials are proven to be successful, researchers will begin commencing on phase two clinical trials. 

During phase two clinical trains, the safety of the vaccine is still being tested, but now the efficacy is being tested as well. This phase additionally involves a much larger sample size, as it usually tests several hundred participants, and lasts longer than phase one to test the longevity of the vaccine. Of late, companies have been combining phase 1/2 in order to test the safety and efficacy in both trials. If phase two clinical trials are proven to be successful, researchers will begin commencing on phase three clinical trials. 

During phase three clinical trials, researchers expand upon the results from phase one and two, and confirm the efficacy and safety of the vaccine, in a drastically larger cohort of subjects (usually a few thousand). Phase three clinical trials also last significantly longer than the prior trials (usually anywhere between 1-4 years) in order to continue testing the longevity of the vaccine. If phase three clinical trials are proven to be successful, the vaccine usually receives FDA approval, and can be distributed. In certain cases a phase four trial can also be commenced, post FDA approval. 

During phase four clinical trials, sometimes called the post market surveillance, is a very long term follow up to test continued safety and efficacy. Many times, a new side effect is noted, years after FDA approval, and is caught during the phase four clinical trials. During these situations, the FDA can issue a warning post approval or even take the treatment off the market for clinical use, if the noted side effect is serious and can cause death or life threatening damage. 

Which Companies are Behind the Current Vaccines?

Vaccines in Phase 3 Trials:

  1. Moderna (Cambridge, MA)

  2. AstraZeneca / Oxford University (Cambridge, England)

  3. Sinovac Biotech (Beijing, China)

  4. Novavax (Gaithersburg, MD) - Phase 3 to begin later this year.

Vaccines in Phase 1 or 2 Trials:

  1. Johnson and Johnson (New Brunswick, NJ)

  2. Sanofi and GSK (Paris and London) 

  3. Merck (Kenilworth, NJ)

  4. Pfizer (New York City, NY)

  5. Novartis (Basel, Switzerland)

  6. Sanofi and Translate Bio (Paris, France and Lexington, MA)

  7. CureVac (Tubingen, Germany)

 
 
 
 
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Companies Behind the Current Vaccines as of Nov, 2020

 
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Updated November. 1, 2020

Johnson and Johnson (New Brunswick, New Jersey) : Phase 3 trials started on September 23 of this year. On October 12, Johnson & Johnson announced that it has paused these trials for an independent safety review due to an unexplained illness in a participant. Such pauses are routine for clinical trials. On Oct. 23, the company announced that the trials will resume.

Moderna (Cambridge, MA) : The phase 3 trials for this company’s vaccine started on July 23. Phase 2 trial results were generally positive healthy subjects including the elderly. The company said that it is on track to deliver 500 million doses of the vaccine starting in 2021. However the vaccine would not be widely available until the first half of 2021.

Novavax (Gaithersburg, MD): On September 24 of this year, the company announced that Phase 3 trials were too begin in the UK, which will evaluate the vaccine in up to 10,000 people, both with and without the underlying conditions. It is unclear as to when the trials will be over or when the actual vaccine will be out.

Bharat Biotech (Hyderabad, India): On October 23 of this year,  the company received approval to begin Phase 3 trial in 26,0000 participants at more than 25 centers across India

Pfizer / BioNTech (New York, NY / Mainz, Germany): On July 27, Pfizer and BioNTech launched a combined Phase 2 and 3 trial, which was then further expanded to include 44,000 people across multiple countries. The project is aiming to seek regulatory review before the end of the year—and hopes to supply 1.3 billion doses by the end of 2021. 

AstraZeneca (Cambridge, England) / Oxford University (Oxford, England): It is in phase three of clinical trials, aiming to recruit up to 50,000 volunteers in Brazil, the United Kingdom, the United States, and South Africa. On September 8, AstraZeneca paused the trials briefly for a safety review due to an adverse reaction in one participant in the U.K. Another volunteer in Brazil died in October, but it is believed not to be related to the vaccine.

Sinovac Biotech (Beijing, China): On July 3, the company was allowed to conduct Phase 3 trials in Brazil for which the company will recruit nearly 9,000 healthcare professionals. Similar trials are going to be conducted in Indonesia and Bangladesh.

Sinopharm (Beijing, China): On September 29,  it was reported that Sinoparm is filing its application to China’s regulatory commission for approval of the vaccine, which could arrive sometime in October. Allegedly, thousands of Chinese civilians have already been vaccinated under the government’s emergency-use approval.

Learn more about this development HERE and HERE

 

Updated November 11,2020

On 11/10/2020, Pfizer announced that preliminary results from the clinical trials of its vaccine showed that it was more than 90% effective. The news was received very positively by both the medical community and the stock market.

Learn more about this development HERE

Updated Nov 17, 2020

On 11/17/2020, the Massachusetts-based company Moderna reported promising preliminary results from its coronavirus vaccine trial. Coming just a week after similar news from Pfizer and BioNTech, the announcement immediately gave the stock market a fresh jolt. It offered more hope that there’s going to be a way out of the pandemic. Early Data Show Moderna’s Coronavirus Vaccine Is 94.5% Effective. And even if Moderna’s vaccine gets the green light from the F.D.A., it will take months to reach widespread distribution.

Learn more about this development HERE

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Nurse May Parsons walks with Keenan at University Hospital in Coventry.

Nurse May Parsons walks with Keenan at University Hospital in Coventry.

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Pfizer

Updated December 10, 2020

On Nov. 9, 2020 Pfizer announced that the data from its Phase 3 clinical trials showed that its COVID-19  vaccine, developed in conjunction with BioNTech, has an efficacy of 95%. Soon after, Moderna announced that its vaccine has an efficacy of 94.1%. Both the companies are planning to get emergency use approval from the FDA soon.

To get a sense of how good these results are, the flu vaccines that we get every year,  are 40 to 60 percent effective at best, because the virus keeps evolving into new forms year after year. By contrast, the measles vaccine is 97 percent effective. Both the vaccines use synthetic Ribonucleic acid (RNA) messengers that use genetic code from the coronavirus to prompt human cells to generate a so-called “spike” protein found on the outside of the virus. The process sets off an immune response from the body, which eventually blocks the actual coronavirus from latching onto cells. Both vaccines need to be stored at extremely cold temperatures.

On Dec. 10, 2020, a panel of experts formally recommended that the FDA authorize the Pfizer vaccine. The agency is likely to do so within days. Health care workers and nursing home residents will most likely be the first recipients.The FDA’s vaccine advisory panel is composed of independent scientific experts, infectious disease doctors and statisticians. With rare exceptions, the FDA follows the advice of its advisory panels. Incidentally, regulators in the UK granted emergency use access to the Pfizer/BioNTech vaccine on Dec. 2, 2020.

The first set of recipients of the vaccine will be health care workers along with residents of long-term care facilities like nursing homes. On Dec. 8, Margaret Keenan, 90, became the first person in the world to receive a clinically approved vaccine. She is from Coventry, a city northwest of London.

Updated August 27, 2021

On Monday, August 23, 2021, the FDA gave full approval to the Pfizer vaccine. Previously it was approved for use on an emergency basis. This was a key step in persuading unvaccinated people to get vaccinated and for employers to mandate it as a precondition for returning to work. In fact, following the announcement, the Pentagon said that it would require all its military personnel to get the Covid-19 vaccine.

Moderna, whose authorized two-dose shot uses similar mRNA technology as the Pfizer vaccine, has said it is still completing rolling data submissions. Johnson & Johnson, whose shot was authorized in February, has said it plans to file for full approval later this year.

Learn more about it HERE. More on Pfizer HERE.

Astra Zeneca

Updated January 4, 2021


On Dec. 30, 2020, the UK government approved the vaccine developed by AstraZeneca and the University of Oxford for emergency use. This was followed by the emergency use approval of the same vaccine by the Indian government on Jan 3, 2021.  The efficacy of this vaccine is only around 70%. However, this vaccine is big news for the developing worlds for a number of reasons. The first thing is that it’s cheap, costing between $3 to $4 per dose around the world as opposed to $25 to $37 a dose for the vaccine developed by Moderna and about $20 a dose for Pfizer’s jab, according to figures reported in Europe. It is easier to transport and store, requiring only standard refrigeration. Finally, it will be more widely available. AstraZeneca and Oxford have worked with manufacturers across the world to produce millions of doses already, and the company says it hopes to make 3 billion more in 2021. 
India also formally approved the emergency use of a coronavirus vaccine developed by a local firm Bharat Biotech. Pfizer, whose vaccine has already been approved for use in jurisdictions including the UK, the US, and the EU, is also seeking emergency authorization in India.
Learn more HERE and HERE
 
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Johnson and Johnson

Updated March 1, 2021

On February 27, 2021 Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.The vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. The Company is expected to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The company also plans  to expand its reach worldwide. The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C).
Learn more about it HERE

Updated April 30, 2021
On April 21, 2021, the CDC lifted an 11-day pause on COVID-19 vaccinations using Johnson & Johnson's single-dose shot, after scientific advisers decided its benefits outweigh a rare risk of blood clot. The government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot, out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died, and seven remain hospitalized. Learn about it HERE

Updated July 15, 2021
On July 12, 2021 U.S. health regulators warned that the Johnson & Johnson Covid-19 vaccine is linked to a very small incidence of cases of a rare neurological disorder called the Guillain-Barré syndrome. Guillain-Barré syndrome is a rare neurological disorder in which the immune system attacks nerves, causing temporary but severe paralysis. The company said that while the chance of such cases is very low, it exceeds the rate of normally reported cases among the general population by a small degree. The FDA recommends use of the vaccine, saying the benefits outweigh the risks. However, the agency attached a warning to the vaccine’s label about the risk of the disorder and made recommendations for treatment. A vaccine from Astra-Zeneca, which has not yet been approved in the US, is also linked to an increased risk of Guillain-Barre syndrome. Learn about it HERE and HERE

 

Covaxin

Updated March 3, 2021

India’s Bharat Biotech said its Covid-19 vaccine, called Covaxin,  has an efficacy of 81%. This has helped revitalize India’s inoculation drive and vaccine-diplomacy efforts. The 24-year-old company is one of the world’s largest producers of vaccines. It is little known outside of the industry (Ref: Prior  Update) but has a portfolio of 16 vaccines and exports to 123 countries. Bharat Biotech started its effort to develop a Covid-19 vaccine in the first half of 2020. India gave the vaccine an emergency approval in January while the third phase of the trial was still underway. This sparked skepticism and questions from experts. The authorization came alongside that of AstraZeneca, known as Covidshield, which is manufactured in India by the Serum Institute, another leading vaccine producer (Ref: Prior  Update). AstraZeneca is producing more than 50 million doses a month. The results of Bharat Biotech’s trials now have alleviated some of the concerns and have put the initial incredulity to rest.

Learn more about it HERE

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Moderna Vaccine for Young Children

Updated March 18, 2021

To date, most of the U.S. Covid-19 vaccination campaign is focused on adults, who are at higher risk of severe disease caused by the coronavirus than children. That is about to change. Moderna said Tuesday, March 16, that the first children, aged between 6 months and 11 years, have received doses in a study, which the company is conducting in collaboration with the National Institute of Allergy and Infectious Diseases and a division of the Department of Health and Human Services. Health officials have suggested that if the studies are positive, junior-high and senior-high students could get access to vaccines in the fall, followed by children of elementary-school age in early 2022.
Learn more about it HERE and HERE

Updated June 20, 2022

On June 18, 2022, the CDC advisory panel voted 12-0 in favor of recommending vaccines from both Moderna and Pfizer for kids aged between 6 month and 5 years. During a two-day meeting, the panelists reviewed data from clinical trials by both pharmaceutical companies, as well data on the need for vaccines for this age group. The vaccine made by Moderna is a two-dose series, given four weeks apart. It was concluded that the benefits far outweigh the risks in approving these vaccines.
Learn more about it HERE

 

Pfizer Vaccine for Adolescents and Children

Updated May 14, 2021

On May 10, 2021, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020, for administration in individuals 16 years of age and older. Previously, COVID-19 vaccines in the U.S. was authorized only for people age 16 and older. The same two shots - three weeks apart - will be given to the adolescents as well. Pfizer is the first vaccine manufacturer to gain emergency use authorization for younger Americans after it demonstrated in a March clinical trial that its vaccine was 100% effective in preventing COVID-19 in study participants who were ages 12 to 15. This authorization comes just in time for summer when many adolescents typically participate in summer activities like camps and group sports. Learn more about it HERE.

Updated November 3, 2021

On Nov. 2, 2021, the CDC, in a 14-0 vote, approved Pfizer/BioNTech’s COVID  vaccination for children between the ages of 5 and 1l. This is the last step before doctors and nurses can administer the vaccine. There are 28 million children who are 5 to 11 years old in the U.S. What about younger children? Pfizer is testing shots for babies and preschoolers and expects data around the end of the year. Moderna is doing the same. The risk of contracting Covid-19 is much lower in children than in adults. That said,  many have been hospitalized, and at least 691 children under the age of 18 have died from Covid-19 in the US,  according to the FDA. Learn more about it HERE and HERE

Updated June 20, 2022

On June 18, 2022, the CDC advisory panel voted 12-0 in favor of recommending vaccines from both Moderna and Pfizer for kids aged between 6 month and 5 years. During a two-day meeting, the panelists reviewed data from clinical trials by both pharmaceutical companies, as well data on the need for vaccines for this age group. The Pfizer-BioNTech vaccine is a three-dose series. The first two shots are given three weeks apart, and the third one eight weeks after the second shot. It was concluded that the benefits far outweigh the risks in approving these vaccines. Learn more about it HERE.

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How about a Pill to Treat Covid-19?

Updated June 24, 2021

The United States government is spending more than $3 billion on developing pills to fight the virus early in the course of infection, potentially saving many lives in the years to come. The new program, announced on June 17, 2021 by the Department of Health and Human Services, will speed up the clinical trials of a few promising drug candidates. The goal here is to make the treatment of the coronavirus similar to that of other diseases like influenza, H.I.V., and hepatitis C. Those ailments can be treated with a simple pill. So far most of the research dollars have been used to develop vaccines. So far, only one antiviral has demonstrated a clear benefit to people in hospitals: Remdesivir.  However, it can only be taken intravenously and not in a pill form. However, it is not that effective if the patient is in the later stages of being infected with the virus. If all goes well, some of those first Covid-19 pills could be ready by the end of the year.

Learn more about it HERE and HERE

 

Vaccine Rollout Status

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Updated July 9, 2021

In May this year, President Biden announced a goal to administer at least one dose of a Covid-19 vaccine to 70% of American adults by the Fourth of July. The administration aimed to have 160 million adults fully vaccinated by then, thereby improving the level of immunity in the country. However, as of July 2, 2021, the nation was at 66.8%. Across the broader population (including children), 54.7% of people had received one shot, and 47.1% of Americans were fully vaccinated. This still puts the US ahead of many countries but behind many in Europe, like Italy, Germany, and Spain, which had logistical problems to deal with. In recent weeks, the progress of America’s roll out has slowed to a crawl due to flagging demand. This underwhelming response could make America vulnerable to the more dangerous Delta variant of the virus.
Learn more about it HERE and HERE.

 

Israel Administers Third Shot of Pfizer Vaccine

Updated July 15, 2021

A third shot of the Pfizer vaccine was administered to severely immunocompromised adults in Israel. The goal of the new program was to raise antibody levels among immunocompromised citizens. This includes cancer patients, recipients of liver transplants, and others who have recently exhibited weakened vaccine protection.

In the United States, it is still unclear where the CDC stands on the need for the third booster shot. Many officials believe that it might be effective for the elderly and the immunocompromised. However, Pfizer still needs an emergency authorization from the FDA - process that could take months. Pfizer officials worry that if the authorization takes too long, the delta variant will cause another surge of the virus this fall amongst the unvaccinated and could infect the vulnerable who are vaccinated.

Learn more about it HERE.

 

Pfizer Booster Shot Emergency Use Approval

Updated September 24, 2021

On Wednesday, Sept. 22, 2021, the FDA authorized a  third dose of the Pfizer-BioNTech Covid-19 vaccine for emergency use in people ages 65 and up, as well as those 18 and older at high risk of exposure to the coronavirus or severe illness. These doses, known as boosters,  are to be given at least six months after people get their second doses of the Pfizer vaccine. That said until the CDC also approves this, these doses cannot be administered. Pfizer originally asked the FDA to consider third doses for everyone 16 and older, six months after they received their second doses. On early Friday, Sept. 24, 2021,  Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention endorsed recommendations for a third dose of the Pfizer Covid-19 vaccine for certain at-risk groups, clearing the way for people to get a booster following the FDA recommendations. The CDC now says that people 65 years and older and residents in long-term care settings should get a booster, and so should people 50 to 64 years old who have an underlying medical condition. Also, those 18 to 49 with underlying medical conditions, and those 18 to 64 who are at an increased risk because of an occupational or institutional setting, "may" get a shot. The CDC says it will be reviewing data in the coming weeks and will make recommendations about those who got the Moderna and the Johnson & Johnson vaccines.

Learn more about it HERE and HERE.

 
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Booster Shots Approval

Updated November 19, 2021

On Friday, November 19, 2021, the FDA authorized both Pfizer/BioNTech’s and Moderna’s boosters for everybody above 18 years of age. Later on Friday, the CDC approved the same. This clears the way for Americans to get booster shots at drugstores, medical centers, or vaccination centers. Much was debated about whether booster shots were really needed. However, as COVID cases rise in many parts of the US and Europe, health officials see booster shots as a way of curtailing the growth of the virus. Learn more about it HERE and HERE

Updated December 10, 2021

On Thursday, December 9, 2021, the FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, to include booster shots for individuals between 16 and 17 years of age. The only condition is that at least six months have elapsed since administering the second dose of the vaccine. Currently, only the Pfizer-BioNTech vaccine is the only one approved for this age group. Learn more about it HERE

Updated January 4, 2022

On Monday, January. 3, 2022 the FDA authorized the use of a third dose of the Pfizer/BioNTech vaccine for children ages 12 to 15 and narrowed the interval for a booster shot eligibility to five months from six. It also authorized the third shot for children aged 5 through 11 years who are immunocompromised. The approvals came around the same time as COVID-19 cases are surging due to the Omicron variant. Learn more about it HERE

Updated September 3, 2022

On Wednesday Aug. 31 2022, the Food and Drug Administration (FDA) authorized the bivalent formulations of vaccines from Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine for emergency use authorizations (EUAs). These vaccines for use will be administered as a single booster dose at least two months following primary or booster vaccination. The new boosters are called “bivalent” because they protect against both the original virus that causes COVID-19 and the Omicron variant BA.4 and BA.5. Previous boosters are called “monovalent” because they were designed to protect against the original virus that causes COVID-19. They also provide some protection against Omicron, but not as much as the updated (bivalent) boosters. Learn more about it HERE and HERE

Updated September 7, 2022

Going forward, COVID-19 could be treated more like the flu, with one annual shot offering year-long protection against severe illness for most people, assuming that there are no new “curve-ball” variants. The government has started off rolling new boosters for this Fall. These target  both the original coronavirus and the two omicron sub-variants. Every fall, people get a new flu vaccine designed to protect against whatever strains of the virus are likely to be circulating that season. The hope is the COVID boosters will act the same way. Learn more about it HERE


Pfizer and Moderna Vaccines Recommended

Updated December 20, 2021

On Thursday, December. 16, 2021, a CDC panel voted to recommend the Pfizer/BioNTech and Moderna vaccines over the one from Johnson and Johnson.  This is due to a small number of very rare but dangerous blood clots. Out of approximately 17 million people in the United States who have gotten the J&J vaccine, there have been nine deaths from the condition called thrombosis with thrombocytopenia. That being said, getting the J&J vaccine was still much safer than getting COVID-19, which is much more likely to cause severe disease or death.

Learn more about it HERE


Emergency Authorization Revoked For Regeneron & Eli Lilly

Updated January 26, 2022

On Monday, January 24, 2022, the FDA said that it was revoking emergency authorization for COVID-19 antibody drugs from Regeneron and Eli Lilly. This is because they don’t work against the omicron variant that now accounts for nearly all U.S. infections. If the drugs prove effective against future variants, the FDA said it could reauthorize their use. Note that these drugs are not a substitute for vaccination and are generally reserved for people who are the most vulnerable, including seniors, transplant recipients, and those with conditions like heart disease and diabetes.

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Paxlovid - COVID Medication

Updated May 9, 2022

Late last year, the FDA issued an emergency use authorization for Pfizer’s Paxlovid tablets for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 88 pounds. Based on research done by Pfizer, Paxlovid should be prescribed within five days of symptoms appearing for the best chance of success. The drug has been shown to lower the risk of severe illness or hospitalization by 89% among people most vulnerable to the worst effects of COVID-19 as long as it was taken within the prescribed window. For now,  in order to qualify for a prescription, you must also have had a positive COVID-19 test result and be at high risk for developing severe COVID-19. You take three Paxlovid pills twice daily for five days for a full course that adds up to 30 pills. The side effects include impaired, diarrhea, increased blood pressure, and muscle aches.

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Nasal Spray - COVID Vaccine

Updated June 10, 2022

As new variants of the corona virus show up, scientists are finding that getting more booster shots, while effective, provides diminishing returns. The problem has arisen because existing COVID-19 vaccines are better at preparing the immune system to fight the virus inside the body than stopping it at the gates. This has led to the development of vaccines that are delivered to the nose via sprays rather than a shot in the arm. They aim to produce strong immune protection in the nose and throat, where most COVID-19 infections gain a foothold. More than a dozen clinical trials of intranasal COVID-19 vaccines are under way, Vietnam, Thailand, Brazil, and Mexico have already started manufacturing the nasal vaccine in anticipation of success in the clinical trials.

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Updated September 8, 2022

On September 4, 2022, China launched the world's first inhalable COVID vaccine, Convidecia Air, which is made by CanSino Biologics and administered through a nebulizer. And on September 6, 2022, India approved a nasally-administered COVID-19 vaccine for emergency use, developed by Bharat Biotech. Nasal vaccines generate an immune response in the respiratory mucosa in the lungs, thereby generating the first line of defense at where the virus enters and causes a lot of damage. In doing so, nasal vaccines could potentially prevent a person from being infected and passing the virus on.

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Novavax COVID-19 Vaccine, Adjuvanted

Updated July 15, 2022

On July 13, 2022, the FDA authorized the emergency use access for the Novavax COVID-19 Vaccine, Adjuvanted. It determined that the vaccine has met the stringent criteria required for its issuance. Adjuvanted is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. 

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Nasal Swab

Updated Aug 27, 2020

A nasopharyngeal swab is a method for collecting a clinical test sample of nasal secretions by inserting a 6-inch long swab (like a long Q-tip) into the cavity between the nose and mouth.Typically The sample is then analyzed for the presence of organisms or other clinical markers for disease.

Abbott Labs was granted an emergency use authorization for a $5 rapid-response COVID-19 antigen test that is roughly the size of a credit card. The low-cost, rapid-response test could be administered in a doctor’s or school nurse’s office and uses technology similar to home pregnancy tests. It returns results in about 15 minutes. This test searches for virus proteins and is intended to be used for patients within seven days of feeling coronavirus symptoms. Abbott said its data demonstrated sensitivity of about 97%

Learn more about this development HERE

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