How Different Companies Developed a Covid-19 Vaccine - Do we Need to Get a Booster Shot?
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Do I need a COVID-19 booster shot? 6 questions answered on how to stay protected?

William Petri, Professor of Medicine, University of Virginia

Mon, August 16, 2021

 

coronavirus vaccine mix and match

 

The increasing prevalence of new coronavirus variants is raising questions about how well protected those who’ve already had their COVID-19 shots are against evolving forms of the SARS-CoV-2 virus. Here, microbiology and infectious disease specialist William Petri of the University of Virginia answers some common questions about COVID-19 booster shots.

 

1. What is a booster shot?

Boosters are an extra dose of a vaccine given to maintain vaccine-induced protection against a disease. They are commonly used to bolster many vaccines because immunity can wear off over time. For example, the flu vaccine needs a booster every year, and the diphtheria and tetanus vaccineevery 10 years.

Boosters are often identical to the original vaccine. In some cases, however, the booster shot has been modified to enhance protection against new viral variants. The seasonal flu vaccine, most notably, requires an annual booster because the flu virus changes so rapidly.

 

2. Do I need to get a COVID-19 booster?

Only if you’re immunocompromised. As of August 2021, the U.S Food and Drug Administration and Centers for Disease Control and Preventionrecommend adding a third shot to the normal vaccination course for people who are severely immunocompromised.

 

3. Why aren’t booster shots recommended for everyone yet?

While vaccine-induced immunity may not last forever, it is not clear when a booster will be needed.    Encouragingly, all of the currently authorized COVID-19 vaccines induce a robust immune memory against the coronavirus. The vaccine teaches your immune system’s memory B cells to produce antibodies when you’re exposed to the virus. Researchers have detected high levels of memory B cells in the lymph nodes of people who received the Pfizer vaccine for at least 12 weeks after they got the shot.  Studies also suggest that authorized COVID-19 vaccines are continuing to offer protection even against emerging strains of the coronavirus. Among one study’s participants, the Johnson & Johnson vaccine had 73% and 82% efficacy 14 days and 28 days post shot, respectively, at warding off severe disease from the beta variant. Another study found the Pfizer vaccine to be 88% effective against the delta variant. The other source of long-lasting antibody responses against the coronavirus is cells called plasmablasts that reside in bone marrow. These cells continuously produce antibodies and do not require boosting to maintain their activity. Fortunately, plasmablasts have been detected in the bone marrow of people who received the COVID-19 vaccine for up to 11 months, indicating some degree of long-lasting immune memory.

 

4. How will I know if I need a booster?

You may need to wait for an outbreak in people who have been vaccinated. Researchers are still figuring out the best way to measure the strength of someone’s vaccine-induced immunity. The COVID-19 vaccines have been so effective that there are not many failures to test. The best candidate to measure are certain antibodies the vaccine induces the immune system to make. They recognize the spike protein that allows the coronavirus to enter and infect cells. Evidence supporting the importance of anti-spike antibodies includes a study showing that the somewhat more effective mRNA vaccines like Pfizer and Moderna generate higher antibody levels in the blood than the adenovirus vector vaccines like Johnson & Johnson and AstraZeneca. In a preliminary study that has not yet been peer-reviewed, anti-spike antibody levels were lower in people who caught COVID-19 after they were vaccinated with the Oxford–AstraZeneca vaccine.

Medical workers would love to be able to give patients a blood test that would tell them how well protected they are or aren’t against COVID-19. That would be a clear indication as to whether a booster shot is needed. But until researchers know for sure how to measure vaccine-induced immunity, the next indication that boosters may be needed are breakthrough infections in older adults who have already been vaccinated. People over the age of 80 make lower levels of antibodies after vaccination, so their immunity may wane sooner than that of the general population. The elderly would also most likely be the most susceptible to new viral variantsthat evade the protection current vaccines provide.

 

5. Who does the FDA and CDC recommend get a third shot?

An extra shot may be necessary for certain immunocompromised people. In one study, 39 of 40 kidney transplant recipients and a third of dialysis patients failed to make antibodies after vaccination. Another study identified 20 patients with rheumatic or musculoskeletal diseases on medications that suppress the immune system who also did not have detectable antibodies. Both of these studies were done after patients received the full vaccine dose.Currently, the CDC recommends that the following people consider getting a third dose:

 

  • People in active cancer treatment
  • People who have received organ transplants and are taking immunosuppressive therapy
  • People who have received a stem cell transplant within the past two years or are taking immunosuppressive therapy
  • People with moderate or severe primary immunodeficiency
  • People with advanced or untreated HIV infection
  • People taking high-dose corticosteroids and other immunosuppressive drugs

 

A third dose has been shown to help in these cases. In one study, one-third of solid organ transplant patients who had a suboptimal response to two doses of the Pfizer or Moderna vaccines were able to develop an antibody response with a third dose. Those who are immunocompromised may wonder if the vaccine they received is successfully generating immunity in their body. A preliminary study that has not yet been peer-reviewed did find that a test that specifically targets the anti-spike antibodies the vaccines trigger may be helpful in determining whether the vaccine worked. But for now, the FDA does not recommend antibody tests to assess immunity.

 

6. Does my third dose need to match my first two?

Likely not. Recent research has shown that mRNA vaccines, like Pfizer and Moderna, can be mixed with adenovirus-based vaccines like AstraZeneca with comparable results.

 

 

New Approach to Vaccines:

 

mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.

 

A Closer Look at How COVID-19 mRNA Vaccines Work:

 

COVID-19 mRNA vaccines give instructions for our cells to make a harmless piece of what is called the “spike protein.” The spike protein is found on the surface of the virus that causes COVID-19.

 

First, COVID-19 mRNA vaccines are given in the upper arm muscle. Once the instructions (mRNA) are inside the immune cells, the cells use them to make the protein piece. After the protein piece is made, the cell breaks down the instructions and gets rid of them.  

 

Next, the cell displays the protein piece on its surface. Our immune systems recognize that the protein doesn’t belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19.

 

At the end of the process, our bodies have learned how to protect against future infection. The benefit of mRNA vaccines, like all vaccines, is those vaccinated gain this protection without ever having to risk the serious consequences of getting sick with COVID-19.

 

COVID 19 mRNA infographic G 508 1

 

Pfizer and Moderna are likely to be the first companies to see their respective vaccines authorized in the United States at the end of 2020. Though their journeys to a COVID-19 vaccine have been eerily similar, the companies themselves could not be more different. Pfizer is a multinational pharmaceutical giant, while Moderna is a small biotechnology company that has never brought a drug to the market. Yet when the COVID-19 pandemic began, both companies bet big on a brand-new vaccine technology called mRNA. Moderna had been working on the technology for years, while Pfizer partnered with a smaller German biotechnology company BioNTech for its mRNA research.

 

 

USA Facts on Vaccinations

 

Click Here to See:  US Coronavirus Vaccine Tracker - Interactive

 

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Health Weather Alert:  Click Here to See the Interactive COVID-19 Risk by State and County

 

 

vaccines on world 1

 

 Vaccinating the world against COVID-19, which has killed more than 3.7 million people to date, is a monumental and complex task -- arguably, the biggest inoculation effort undertaken in history. In addition to developing safe and effective vaccines in record time, the logistics of rolling out those doses have been immense and raised questions about access and equity, specifically for poorer countries around the world and at-risk populations in the U.S. and elsewhere.  And experts say vaccinating the world is a matter of necessity, specifically vulnerable populations -- a key to reducing the burden on health systems and stemming the tide of contagious variants. The contrasts between haves and have-nots couldn't be starker -- while more than half the adults in the U.S. are fully inoculated much of the world lags behind. And as the U.S. struggles with unused doses of vaccines and hesitancy, some countries, such as India, Nepal, South Africa and those in South America are facing staggering outbreaks and losses.  Worldwide, more than 1.98 billion COVID-19 single vaccine doses have been administered, according to Our World in Data, but that does not account for the two doses required in many cases nor does it always indicate where doses have been administered. With more than 7.7 billion people in the world, there remains a long way to go in the battle against COVID-19.

 

vaccines to tye world

 

President Biden Announced a  Historic Vaccine Donation: Half a Billion Pfizer Vaccines to the World’s Lowest-Income Nation.  500 million life-saving vaccines to be delivered by June of next year, including 200 million to be delivered by the end of 2021.  Donation will serve as the foundation for a coordinated effort by the world’s democracies to vaccinate people around the world

 

 

 

 

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The U.S. is the second-biggest producer, at 27%, but its bulk contracts with manufacturers keep doses produced in the U.S. from leaving.The global supply of the Pfizer/BioNTech vaccine is coming from the EU, which is exporting 48% of its production, vs. 0% from the U.S. according to Airfinity, a science information and analytics company.Moderna is using its European facilities to supply Canada with doses, because all doses produced at U.S. sites are going toward the 300 million the U.S. has purchased.  The Biden administration took a tentative first step last week, offering around 4 million total doses of the Oxford/AstraZeneca vaccine — which isn’t authorized for use in the U.S. — to Mexico and Canada. The administration has also pledged $4 billion to the global COVAX initiative and more still to help increase supplies to Asia. But it’s holding tight to virtually every dose produced in the U.S. "We're going to have excess supply," said Zeke Emanuel, vice provost for global initiatives at the University of Pennsylvania, who was a member of Biden’s coronavirus task force during the transition.

 

 

Pfizer declined an initial research investment from the US government’s Operation Warp Speed, a multibillion-dollar program to accelerate the development and distribution of COVID-19 vaccines. But Moderna has been partnered with the government from the start, enjoying a longstanding research collaboration with the National Institutes of Health, accepting $955 million in funding from the Biomedical Advanced Research and Development Authority (BARDA). Both companies have accepted Operation Warp Speed funding in exchange for a promise that the first 100 million doses of their respective vaccines will be delivered to the U.S. government.  And when it comes to their vaccines, both Pfizer and Moderna’s are quite similar.

 

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Days Left by Country Until Herd Immunity to Covid-19  is Reached Through Vaccinations Around the World 

 

 

 

“They’re using something called an mRNA technology, which is relatively new in vaccine development,” said Azra Behlim, senior director of pharmacy sourcing and program services at Vizient.

 

 

Compared to some other vaccine technologies, mRNA is a more delicate product, Behlim told ABC News, meaning it needs to be kept frozen for long term storage. Moderna’s vaccine can be kept in normal freezer temperatures, like the freezer you have at home. Pfizer’s vaccine, meanwhile, must be kept in a specialized ultra-cold freezer at -94 degrees Fahrenheit. Once thawed, the Moderna vaccine can be kept in a normal refrigerator for a month, while Pfizer’s can only be kept in a typical fridge for five days.

 

Covid virus image w needle 

 

“Some of those cold chain storage issues that the Pfizer vaccine brought up ... could be alleviated with [Moderna's] vaccine,” said Dr. Colleen Kelley, associate professor of medicine at Emory University School of Medicine and principal investigator for the Moderna study at the Ponce de Leon Center. “This is good news for places that may not have access to that ultra-cold storage,” said Kelley. That could include more rural parts of America.  Operation Warp Speed Vaccine Development Lead Dr. Matt Hepburn said, "the fridge-for-a-month distribution point we made really enables for a much more distributed model to get the vaccine out there, potentially for example in very rural areas."

 

 

But with limited supplies of each vaccine available at first, enough to vaccinate only 20 million Americans by the end of the year, experts agree the U.S. needs multiple vaccines to fight the pandemic. That includes not only Pfizer and Moderna's vaccine but also even more that are further behind in development.   Two other companies that received funding for clinical research from Operation Warp Speed -- AstraZeneca and Johnson & Johnson -- had brief setbacks when their late-stage trials were paused over safety concerns. But those trials are now back up and running and may have data available in the coming weeks and months. “We will not see the other side of this pandemic without an effective vaccine, and multiple effective vaccines,” Kelley said.

 

J and J vaccine FDA approved

FDA Advisory Panel Endorses Third Covid-19 Vaccine - Johnson & Johnson - for Emergency Use  - 2 26 2021

 

Johnson & Johnson’s one-dose COVID-19 vaccine appeared safe and effective in trials, the U.S. Food and Drug Administration said, paving the way for its approval for emergency use  on February 26, 2021.  The vaccine was 66% effective at preventing moderate to severe COVID-19 in a 44,000 person global trial, the FDA said in documents ahead of a Friday meeting of independent experts who will advise the agency on emergency authorization. New data provided by J&J to the FDA showed the vaccine was 64% effective at stopping moderate to severe cases of COVID-19 after 28 days in thousands of trial participants in South Africa where a worrying new variant has swept across the country.

 

Johnson Johnsons COVID 19 vaccine

 

Overall, the vaccine was 100% effective at stopping hospitalization 28 days after vaccination, compared with 85% at 14 days, and there were no COVID-19 deaths among those who received the shot rather than a placebo. J&J also said the data suggested its vaccine cut down on asymptomatic infections, which experts said was another sign COVID-19 vaccines may indeed stop transmission of the disease.

 

Vaccine 1

 

“Most encouraging to me were the data in South Africa,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the FDA advisory committee that will make its recommendation on Friday. “That you could still get protection against medically attended illnesses - meaning hospitalization, ICU admission and deaths from that vaccine against the South African strain, I thought that was really encouraging.”

 

 

The vaccine is administered in a single dose and can be stored in normal fridges, in contrast to the Pfizer and Moderna shots which need two doses and must be kept in freezers.  The J&J vaccine is also considered essential in the global vaccination effort due to its routine storage requirements and is already being rolled out to 500,000 healthcare workers in South Africa. J&J said in documents submitted to the FDA that in a preliminary analysis of its trial, it found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88% efficacy rate. While fighting asymptomatic infection was not the primary goal of the trial, which studied the vaccine’s ability to stop moderate to severe COVID-19, the reduction of asymptomatic cases implies the shot can also cut transmission of the disease.  “The data is consistent with the fact that these coronavirus vaccines, including the J&J vaccine, do have an impact which is significant on asymptomatic spread,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

 

covid ilustration and vaccine 1

 

However, he said some public health authorities may ask to see more robust data before being persuaded.  The effectiveness of the one-dose vaccine varied over time. In Brazil, where a similar variant to the one in South Africa is circulating, the vaccine was 66% after 14 days, rising to 68% at 28 days. In the United States, the effectiveness fell from 74% at 14 days to 72% two weeks later. Overall, only two vaccine recipients developed COVID-19 severe enough to need medical intervention after 14 days and that dropped to zero after 28 days. J&J has said it sees rising immunity from its vaccine until at least 28 days after injection. The drugmaker has said it expects sustained - or even improved - protection over time.

 

Covid CUp Bottles vaccines

 

SIDE EFFECTS:  Three vaccine recipients had severe side effects in the trial that were likely related to the vaccine, but the FDA said its analysis did not raise any specific safety concerns that would preclude issuance of an emergency use authorization. The FDA said the most common reactions were injection site pain at 48.6%, headache at 39%, fatigue at 38.2% and myalgia at 33.2%. Other side effects included a fever in 9% of participants and a high fever in 0.2% of those who received the vaccine. The regulator said one case of pericarditis, a heart disease, may have been caused by the vaccine. It said cases of a rare disorder, Guillain-Barre Syndrome, were unlikely to be related to the shot though data was insufficient to determine whether the vaccine had caused these side effects.

 

AstraZeneca Logo Coronavirus Vaccine

AstraZeneca’s U.S. Trial Shows Coronavirus Vaccine is 79 Percent Effective

 

Oxford researchers, who developed the easily transported $4 shot for the British-Swedish pharmaceutical giant AstraZeneca, said their coronavirus vaccine is “safe and highly effective, adding to previous trial data from the United Kingdom, Brazil and South Africa, as well as real-world impact data from the United Kingdom.”  An independent monitoring board combed through the data to look for any cases of blood clotting events similar to those that caused the vaccination effort to be suspended in many European countries. While vaccination was started again after a pause, it undermined confidence in the vaccine. The independent board found no suggestion that the vaccine carried an increased risk of clotting.  The trials included 32,449 adult participants in all age groups, most of them in the United States. The volunteers received either two standard doses of the Oxford-AstraZeneca vaccine or a placebo, at a four-week interval, the researchers said.

 

 

The company said in its release it will apply for emergency authorization from the Food and Drug Administration “in the coming weeks,” but a question that has emerged recently is whether the United States, which President Biden has promised will have enough vaccine for all adults by the end of May, will need the vaccine. Fauci said it was too soon to know how it would fit into the U.S. vaccine portfolio “The one thing that one can say for sure, that this is good for the world, because it’s a cheap vaccine. It’s got good results. They will likely be able to produce enough for a lot of different countries,” Fauci said.

 

AstraZeneca box

 

The Oxford researchers said that the Data and Safety Monitoring Board in the United States “reported no safety concerns among the participants receiving at least one dose of the vaccine.”The results were reported in a pair of brief news releases from the pharmaceutical company and the university scientists.  The drug company said, “vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.” The U.S. government has preordered 300 million doses of the AstraZeneca vaccine.

 

AstraZeneca bottles in freezer

 

The FDA has already given emergency authorization to vaccines from U.S. firms Pfizer, with German partner BioNTech; Moderna; and Johnson & Johnson. The Pfizer-BioNTech and Moderna vaccines, which require two doses, have shown up to 95 percent efficacy against symptomatic covid-19. The Pfizer-BioNTech vaccine requires special handling and must be kept at especially cold temperatures in special freezers.

 

 

An Israeli-American pharmaceutical company is preparing to launch a Phase I clinical trial for what could become the world’s first oral COVID-19 vaccine. Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company based on technology developed by Hadassah-University Medical Center, announced over the weekend a joint venture with Premas Biotech to develop a novel oral vaccine. Together they formed the company Oravax Medical Inc. The vaccine is based on Oramed’s “POD” oral delivery technology and Premas’s vaccine technology.