There are now two promising potential COVID vaccines. This is what we know about them.

Adrianna RodriguezKaren WeintraubUSA TODAY 11/16/20

Nearly seven months after Operation Warp Speed was created, Americans are finally starting to get answers about the candidate vaccines that could potentially slow the coronavirus pandemic.

Operation Warp Speed, the White House-led task force on coronavirus vaccine treatment and development, was created on May 15. Since then, vague and contradicting timelines made by both the Trump administration and leading scientists have muddled predictions about when a COVID-19 vaccine would be available to the public.

However, two big companies leading the race for a vaccine have released promising results from their Phase 3 trials.

Here’s what we know about both trials and what they might mean for the future of the pandemic.

What are the leading COVID-19 candidate vaccines?

Pfizer and the German biotechnology company BioNTechdeveloped one of the candidate vaccines. They announced early findings of their vaccine, BNT162b2, on Nov. 9.https://6926b6316bce5dd601f0850aef7a054e.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.html

Moderna, a Cambridge, Massachusetts-based biotechnology company, released data early Monday on its candidate vaccine, mRNA-1273, which was developed in collaboration with the U.S. government.

Both results are preliminary, with final results expected in as soon as a few weeks.

How effective are the candidate vaccines and what does that mean?

Pfizer released interim results that showed its candidate vaccine was more than 90% effective, after 94 patients developed COVID-19 – the vast majority of whom received the placebo. 

Out of Pfizer’s 44,000 volunteers,  half the participants received a placebo and half the vaccine, so the new data shows that more people who received the placebo than the vaccine came down with COVID-19.

They were protected a week after the second dose of the vaccine. The two doses are given 21 days apart. Pfizer/BioNTech will do a final check of effectiveness when 164 study participants have fallen ill.

Moderna’s vaccine appears to be 94.5% effective against the disease, after 95 people out of the 30,000 volunteers came down with COVID-19, 90 of whom received the placebo. Eleven people – all in the placebo group – developed “serious” cases of the disease.

A final analysis is expected to include 151 trial volunteers, by which point, statistically, the company can be 90% sure that its findings will hold true.

Are there any side effects to the Moderna, Pfizer vaccines?

Both candidate vaccines reported mild or moderate side effects, mostly pain at the injection site, fatigue and aching muscles and joints for a day or two.

“A sore arm and feeling crummy for a day or two is a lot better than COVID,” said Dr. William Schaffner, professor of health policy and of preventive medicine at the Vanderbilt University School of Medicine.

What makes Pfizer, Moderna candidates different from others?

The Chinese government publicly released the genetic sequence of the virus that causes COVID-19, called SARS-CoV-2, in mid-January, a few weeks after recognizing an outbreak was underway. Scientists focused on the sequence for the so-called “spike protein” found on the surface of the virus, which allows the virus to attach itself to host cells to infect them.

The Moderna and Pfizer vaccines are based on delivering strands of genetic material to turn people’s cells into spike protein factories. The spike proteins created by the body aren’t dangerous because the rest of the virus isn’t present, however, the body now sees the protein and designs immune soldiers to fight it upon future exposure.

What a vaccine volunteer has to say:I volunteered for Moderna’s COVID vaccine trial. Here’s why I think I got the vaccine, not a placebo

This technology has never been used before in an approved vaccine, and other vaccines have taken 15-20 years to develop and test. The mRNA technology was chosen this time because scientists knew it could be developed quickly. Other COVID-19 vaccine candidates being supported by the U.S. government target the spike protein via a carrier virus or tiny particle.

When can I get a COVID-19 vaccine?

Before the companies can apply to the U.S. Food and Drug Administration for authorization to provide their vaccine to the public, they must  clear several more hurdles.

About half the trial participants must be two months past their second shot, to prove that the candidate vaccines are safe. If someone were to develop a severe vaccine reaction, it’s likely to happen within six weeks of receiving it. Pfizer will pass that safety milestone this week. Moderna will take longer because it took longer to enroll trial participants.

The final hurdle concerns production. Both companies will have to show that they can safely produce their vaccine at scale. Pfizer said it will provide the FDA that information before this week, but it’s not clear when Moderna will complete this process.

Finally, the FDA will take some time to review each application, as  will an independent committee. While no one knows how long this will take, the regulatory agency is expected to an issue an emergency use authorization for the Pfizer/BioNTech vaccine before the end of the year.

President Donald Trump has promised that vaccine would be distributed within 24 hours of an FDA authorization. It would first go to front-line health care workers.

Moderna said Monday it will have 20 million doses available by the end of this year and another 500 million to 1 billion next calendar year. Pfizer has said it will have as much as 50 million doses of its vaccine manufactured by the end of this year, and another 1.3 billion next year.

While the gears have been oiled up to start cranking out vaccines, scientists have predicted  vaccines won’t be available to the general public until summer or fall of 2021.

Follow Adrianna Rodriguez and Karen Weintraub on Twitter: @AdriannaUSAT @kweintraub

Academic rigor, journalistic flair

What monoclonal antibodies are – and why we need them as well as a vaccine

November 16, 2020 8.24am EST

Author

1. Rodney E. RohdeProfessor Clinical Laboratory Science, Texas State University

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• When President Trump was diagnosed with COVID-19, one of the cutting-edge experimental therapies he received was a mixture of monoclonal antibodies. But now a vaccine may soon be available. So are other therapies necessary or valuable? And what exactly is a monoclonal antibody?

Over the past few months, the public has learned about many treatments being used to combat COVID-19. An antiviral like remdesivir inhibits the virus from replicating in human cells. Convalescent plasma from the blood of donors who have recovered from COVID-19 may contain antibodies that suppress the virus and inflammation. Steroids like dexamethasone may modify and reduce the dangerous inflammatory damage to the lungs, thereby slowing respiratory failure.

The FDA issued emergency use authorization for Eli Lilly’s monoclonal antibody, called bamlanivimab, and Regeneron is waiting for FDA’s green light for its antibody treatment. Monoclonal antibodies are particularly promising in therapy because they can neutralize the SARS-CoV-2 virus, which causes COVID-19, and block its ability to infect a cell. This might be a lifesaving intervention in people who are unable to mount a strong natural immune response to the virus – those over 65 or with existing conditions that make them more vulnerable.

I’ve worked in public health and medical laboratories for decades, specializing in the study of viruses and other microbes. Even when a vaccine for COVID-19 becomes available, I see a role for monoclonal antibody therapy in getting the pandemic under control.

Why should we care?

Until a large percentage of a population has immunity to an infectious disease – either through a vaccine or the unchecked spread through a community – the world must rely on other weapons in our war against the COVID-19 pandemic.

Along with the previously mentioned therapies, monoclonal antibodies can offer us another tool to neutralize the virus once it causes an infection.

These man-made antibodies offer the world the possibility of immunotherapy similar to the use of convalescent plasma but with a more targeted and accurate action. While a vaccine will ultimately help protect the public, vaccination will not be an instantaneous event, delivering vaccine to 100% of the population. Nor do we know how effective it will be.

The impact of a vaccine also isn’t instantaneous. It takes several weeks to generate a powerful antibody response. In the interim, monoclonal antibodies could help mop up virus that is multiplying in the body.

Antibody 101

An antibody is a Y-shaped protein naturally produced by our body’s immune system to target something that is foreign, or not part of you. These foreign bodies are called antigens and can be found on allergens, bacteria and viruses as well as other things like toxins or a transplanted organ.

A monoclonal antibody treatment mimics the body’s natural immune response and targets foreign agents, like a virus, that infect or harm people. There are also monoclonal antibodies that pharmaceutical companies have designed that target cancer cells. Monoclonal antibodies are one of most powerful types of medicine. In 2019 seven of the top 10 best-selling drugs were monoclonal antibodies.

For President Trump, the experimental treatment made by the pharmaceutical company Regeneron included two antibodies.

Typically the spike protein on the coronavirus fits perfectly into the ACE2 receptor on human cells, a protein common in lung cells and other organs. When this connection happens, the virus is able to infect cells and multiply inside them. But monoclonal antibodies can slow or halt the infection by attaching to the viral spike protein before it reaches the ACE2 receptor. If this happens, the virus becomes harmless because it can no longer enter our cells and reproduce.

How are monoclonal antibodies created?

Monoclonal antibodies that neutralize the coronavirus are complicated to manufacture and produce. They must be made inside cells taken from a hamster’s ovary and grown in gigantic steel vats. The antibodies that these cells manufacture must then be extracted and purified. Unfortunately these monoclonal antibodies, which have been used for other illnesses for years, are often quite expensive.

Regeneron’s two antibodies are targeted to the spike protein of SARS-CoV-2 – the protrusions on the surface of virus that give it a crown-like look and are critical for infecting human cells.

One of Regeneron’s two antibodies is a replica, or clone, of an antibody harvested from a person who recovered from COVID-19. The second antibody was identified in a mouse that was biologically engineered to have a human immune system. When this mouse was injected with the spike protein, its human immune system generated antibodies against it. One of the most effective mouse antibodies was then harvested and used to form part of this therapy.

Eli Lilly’s monoclonal antibody therapy, bamlanivimab, was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Both companies have in place large-scale manufacturing with robust, global supply chains in place to produce the monoclonal antibodies, with many global manufacturing sites to ramp up supply. Eli Lilly has received FDA approval, and Regeneron is still awaiting approval. Unfortunately, there will likely be a shortage of the antibodies in the early going of approvals.

Monoclonal antibodies plus a vaccine

Monoclonal antibodies will be able to complement vaccines by offering rapid protection against infection. When they are given to an individual, monoclonal antibodies provide instantaneous protection for weeks to months. Vaccines take longer to provide protection since they must challenge the immune system. But the advantage of a vaccine is that they usually provide long-term protection.

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Regeneron’s and Eli Lilly’s products are both delivered by intravenous injection, after which the patient must be monitored by health care professionals. Since they offer immediate protection, the implications to treat or provide protection to high-risk populations is immense.

These medicines have the potential to treat infected patients or prevent infection of essential health care and public health professionals on the front line of this pandemic. Monoclonal antibodies could also be useful for older people, young children and immunocompromised people for whom vaccines either don’t work or can be dangerous.

What can I say?

Sammy Hagar has survived the break-up of Van Halen and has gone on to do well for himself. Sammy is originally from my turf, San Bernardino County – the city of Fontana. He played in and around the area for sometime. Unfortunately, I can’t say ‘I knew him when.’

You can see more of Sammy on his: http://www.redrocker.com/news site where he smooches with his wife, Kari. They are a cute couple.

Will follow up with a little more on Nancy Wilson of Heart and Van Halen.

Just bought an MP3 – Living in a Blue Dream – Joe Satriani. wow!

I think I have bought two of his Surfing with the Alien albums. This character is based on the Silver Surfer character from Marvel Comics. I loved Joe when he still had hair, but…..the music is just as great as ever. CW