New Hopes for a COVID-19 Vaccine

An Update from Pfizer Inc.

Since the beginning of the COVID-19 pandemic in March 2020, pharmaceutical companies all around the world have answered the call to action for creating a vaccine for the virus (Sars-CoV-2) that causes COVID-19. As of Monday, November 9th, Pfizer Inc. released results from their latest COVID-19 vaccine clinical trial. Pfizer Inc. is one of the largest pharmaceutical companies in the world and is based out of New York City, Ny. In the third phase of testing, approximately 43,000 volunteers across the United States participated in both rounds of vaccine administration. Following the gold-standard of research, the study was a blind Randomized Control Clinical Trial. This means that people were randomly assigned to one of two groups; either the vaccine group or the placebo group and the participants didn’t know which group they were in making the study blinded. Both groups received two rounds of injections where the vaccine group received the actual vaccine and the placebo group received an injection of saline.

The final results of the study reported that 94 volunteers had contracted COVID-19. For the 94 people that contracted COVID-19, 90% were protected from the virus via vaccine and 10% were not. This indicates that the vaccine has an efficacy rate of approximately 90% after the two doses are received. I should mention that it is looking like this vaccine is most likely going to be a series. This means that people will have to receive multiple rounds to gain immunity. Other vaccines that must be received in series include the ones for Human Papillomavirus (HPV) and Measles, Mumps, Rubella (MMR).

Outlined by the CDC, vaccine testing and approval occurs in 5 stages. These stages are the exploratory stage, the preclinical stage; the regulatory review and approval stage; the manufacturing stage; and the quality control stage. Because Pfizer Inc. has seen such promising results from the clinical stage for the COVID-19 vaccine, Pfizer Inc. has current projections predicting that they will be able to manufacture 50 million doses before the end of the year, and 1.3 billion by the end of 2021.

Although there is a lot unknown about the future of the COVID-19 vaccine – such as who will be eligible to receive it, how much it will cost, and whether it will be an annual vaccine or not; there is a lot of hope on the horizon. It is also extremely important to remember that the day the vaccine is officially released to the public is not the day that the pandemic is over. It is simply the first day of the end stage of the pandemic. Until the majority of the general public has been vaccinated, it is crucial that we stay diligent about masking up, staying physically distant, and practicing good hygiene. To learn more from Pfizer Inc. and their vaccine trials, use this link!

5 Important Questions About Pfizer’s COVID Vaccine

By Arthur Allen

Wednesday, November 11, 2020 (Kaiser News) — Pfizer’s announcement on Monday that its COVID-19 shot appears to keep nine in 10 people from getting the disease sent its stock price rocketing. Many news reports described the vaccine as if it were our deliverance from the pandemic, even though few details were released.

There was certainly something to crow about: Pfizer’s vaccine consists of genetic material called mRNA encased in tiny particles that shuttle it into our cells. From there, it stimulates the immune system to make antibodies that protect against the virus. A similar strategy is employed in other leading COVID-19 vaccine candidates. If mRNA vaccines can protect against COVID-19 and, presumably, other infectious diseases, it will be a momentous piece of news.

“This is a truly historic first,” said Dr. Michael Watson, the former president of Valera, a subsidiary of Moderna, which is currently running advanced trials of its own mRNA vaccine against COVID-19. “We now have a whole new class of vaccines in our hands.”

But historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.

So did Pfizer’s stock deserve its double-digit percentage bump? The answers to the following five questions will help us know.

1. How long will the vaccine protect patients?

Pfizer says that, as of last week, 94 people out of about 40,000 in the trial had gotten ill with COVID-19. While it didn’t say exactly how many of the sick had been vaccinated, the 90% efficacy figure suggests it was a very small number. The Pfizer announcement covers people who got two shots between July and October. But it doesn’t indicate how long protection will last or how often people might need boosters.

“It’s a reasonable bet, but still a gamble that protection for two or three months is similar to six months or a year,” said Dr. Paul Offit, a member of the Food and Drug Administration panel that is likely to review the vaccine for approval in December. Normally, vaccines aren’t licensed until they show they can protect for a year or two.

Continued

The company did not release any safety information. To date, no serious side effects have been revealed, and most tend to occur within six weeks of vaccination. But scientists will have to keep an eye out for rare effects such as immune enhancement, a severe illness brought on by a virus’s interaction with immune particles in some vaccinated persons, said Dr. Walt Orenstein, a professor of medicine at Emory University and former director of the immunization program at the Centers for Disease Control and Prevention.

2. Will it protect the most vulnerable?

Pfizer did not disclose what percentage of its trial volunteers are in the groups most likely to be hospitalized or to die of COVID-19 — including people 65 and older and those with diabetes or obesity. This is a key point because many vaccines, particularly for influenza, may fail to protect the elderly though they protect younger people. “How representative are those 94 people of the overall population, especially those most at risk?” asked Orenstein.

Both the National Academy of Medicine and the CDC have urged that older people be among the first groups to receive vaccines. It’s possible that vaccines under development by Novavax and Sanofi, which are likely to begin late-phase clinical trials later this year, may be better for the elderly, Offit noted. Those vaccines contain immune-stimulating particles like the ones contained in the Shingrix vaccine, which is highly effective in protecting older people against shingles disease.

3. Can it be rolled out effectively?

The Pfizer vaccine, unlike others in late-stage testing, must be kept supercooled, on dry ice around 100 degrees below zero, from the time it is produced until a few days before it is injected. The mRNA quickly self-destructs at higher temperatures. Pfizer has devised an elaborate system to transport the vaccine by truck and specially designed cases to vaccination sites. Public health workers are being trained to handle the vaccine as we speak, but we don’t know for sure how well it will do if containers are left out in the Arizona sun too long. Mishandling the vaccine along the way from factory to patient would render it ineffective, so people who received it could think they were protected when they were not, Offit said.

Continued

4. Could a premature announcement hurt future vaccines?

There’s presently no way to know whether the Pfizer vaccine will be the best overall or for specific age groups. But if the FDA approves it quickly, that could make it harder for manufacturers of other vaccines to carry out their studies. If people are aware that an effective vaccine exists, they may decline to enter clinical trials, partly out of concern they could get a placebo and remain unprotected. Indeed, it may be unethical to use a placebo in such trials. Many vaccines will be needed in order to meet global demand for protection against COVID-19, so it’s crucial to continue additional studies.

5. Could the Pfizer study expedite future vaccines?

Scientists are vitally interested in whether the small number who received the real vaccine but still got sick produced lower levels of antibodies than the vaccinated individuals who remained well. Blood studies of those people would help scientists learn whether there is a “correlate of protection” for COVID-19 — a level of antibodies that can predict whether someone is protected from the disease. If they had that knowledge, public health officials could determine whether other vaccines under production were effective without necessarily having to test them on tens of thousands of people.

But it’s difficult to build such road maps. Scientists have never established correlates of immunity for pertussis, for example, although vaccines have been used against those bacteria for nearly a century.

Still, this is good news, said Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health and a former FDA deputy commissioner. He said: “I hope this makes people realize that we’re not stuck in this situation forever. There’s hope coming, whether it’s this vaccine or another.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Study Confirms It’s Possible to Catch COVID Twice

August 24, 2020 — Researchers in Hong Kong say they’ve confirmed that a person can be infected with COVID-19 twice.There have been sporadic accounts on social media sites of people who say they’ve gotten COVID twice. But scientists have been skeptical about that possibility, saying there’s no evidence it happens.The new proof comes from a 33-year-old man in Hong Kong who first caught COVID-19 in March. He was tested for the coronavirus after he developed a cough, sore throat, fever, and a headache for 3 days. He stayed in the hospital until he twice tested negative for the virus in mid-April.

On Aug. 15, the man returned to Hong Kong from a recent trip to Spain and the U.K., areas that have recently seen a resurgence of COVID-19 cases. At the airport, he was screened for COVID-19 using a test that checks saliva for the virus. He tested positive, but this time, had no symptoms. He was taken to the hospital for monitoring. His viral load — the amount of virus he had in his body — went down over time, suggesting that his immune system was taking care of the intrusion on its own.

The special thing about his case is that each time he was hospitalized, doctors sequenced the genome of the virus that infected him. It was slightly different from one infection to the next, suggesting that the virus had mutated — or changed — in the 4 months between his infections. It also proves that it’s possible for this coronavirus to infect the same person twice.

Experts with the World Health Organization responded to the case at a news briefing Monday.

“What we are learning about infection is that people do develop an immune response. What is not completely clear yet is how strong that immune response is and for how long that immune response lasts,” said Maria Van Kerkhove, PhD, an infectious disease epidemiologist with the World Health Organization in Geneva, Switzerland.

A study on the man’s case is being prepared for publication in the journal Clinical Infectious Diseases. Experts say the finding shouldn’t cause alarm, but it does have important implications for the development of herd immunity and efforts to come up with vaccines and treatments.

“This appears to be pretty clear-cut evidence of reinfection because of sequencing and isolation of two different viruses,” says Gregory Poland, MD, an expert on vaccine development and immunology at the Mayo Clinic in Rochester, MN. “The big unknown is how often is this happening,” he says. More studies are needed to learn whether this was a rare case or something that is happening often.

Past Experience Guides Present

Until we know more, Poland says the possibility of getting COVID-19 twice shouldn’t make anyone worry.

This also happens with other kinds of coronaviruses — the ones that cause common colds. Those coronaviruses change slightly each year as they circle the globe, which allows them to keep spreading and causing their more run-of-the-mill kind of misery.

It also happens with seasonal flu. It is the reason people have to get vaccinated against the flu year after year, and why the flu vaccine has to change slightly each year in an effort to keep up with the ever-evolving influenza virus.

“We’ve been making flu vaccines for 80 years, and there are clinical trials happening as we speak to find new and better influenza vaccines,” Poland says.

There has been other evidence the virus that causes COVID-19 can change this way, too. Researchers at Howard Hughes Medical Center, at Rockefeller University in New York, recently used a key piece of the SARS-CoV-2 virus — the genetic instructions for its spike protein — to repeatedly infect human cells. Scientists watched as each new generation of the virus went on to infect a new batch of cells. Over time, as it copied itself, some of the copies changed their genes to allow them to survive after scientists attacked them with neutralizing antibodies. Those antibodies are one of the main weapons used by the immune system to recognize and disable a virus.

Though that study is still a preprint, which means it hasn’t yet been reviewed by outside experts, the authors wrote that their findings suggest the virus can change in ways that help it evade our immune system. If true, they wrote in mid-July, it means reinfection is possible, especially in people who have a weak immune response to the virus the first time they encounter it.

Good News

That seems to be true in the case of the man from Hong Kong. When doctors tested his blood to look for antibodies to the virus, they didn’t find any. That could mean that he either had a weak immune response to the virus the first time around, or that the antibodies he made during his first infection diminished over time. But during his second infection, he quickly developed more antibodies, suggesting that the second infection acted a little bit like a booster to fire up his immune system. That’s probably the reason he didn’t have any symptoms the second time, too.

That’s good news, Poland says. It means our bodies can get better at fighting off the COVID-19 virus and that catching it once means the second time might not be so bad.But the fact that the virus can change quickly this way does have some impact on the effort to come up with a vaccine that works well.“I think a potential implication of this is that we will have to give booster doses. The question is how frequently,” Poland says. That will depend on how fast the virus is changing, and how often reinfection is happening in the real world.

“I’m a little surprised at 4½ months,” Poland says, referencing the time between the Hong Kong man’s infections. “I’m not surprised by, you know, I got infected last winter and I got infected again this winter,” he says.

It also suggests that immune-based therapies such as convalescent plasma and monoclonal antibodies may be of limited help over time, since the virus might be changing in ways that help it outsmart those treatments.

Convalescent plasma is essentially a concentrated dose of antibodies from people who have recovered from a COVID-19 infection. As the virus changes, the antibodies in that plasma may not work as well for future infections.

Drug companies have learned to harness the power of monoclonal antibodies as powerful treatments against cancer and other diseases. Monoclonal antibodies, which are mass-produced in a lab, mimic the body’s natural defenses against a pathogen. Just like the virus can become resistant to natural immunity, it can change in ways that help it outsmart lab-created treatments. Some drug companies that are developing monoclonal antibodies to fight COVID-19 have already prepared for that possibility by making antibody cocktails that are designed to disable the virus by locking onto it in different places, which may help prevent it from developing resistance to those therapies.

“We have a lot to learn,” Poland says. “Now that the proof of principle has been established, and I would say it has with this man, and with our knowledge of seasonal coronaviruses, we need to look more aggressively to define how often this occurs.”

Sources

Clinical Infectious Diseases, Aug. 24, 2020.

Gregory Poland, MD, consultant, Division of Pediatric Infectious Diseases; consultant, Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, MN.

Maria Van Kerkhove, PhD, infectious disease epidemiologist, World Health Organization, Geneva, Switzerland.

 

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Coronavirus Daily Digest: May 29, 2020

The CDC presents expansive guidelines for reopening American offices. Infections and deaths are still rising in a dozen states. And for the first time ever, the Boston Marathon is canceled. Here’s the latest news on coronavirus:

  • Let’s talk reopening: The CDC has issued sweeping new guidelines on the safest ways to reopen offices. In New York City, Mayor Bill de Blasio expects up to 400,000 residents to head back to work in the first half of next month, as the city prepares to begin lifting some of its most stringent coronavirus restrictions. Illinois is joining many of its neighboring Midwest states in reopening some retail shops, restaurants, salons, and other businesses today, but Chicagoans will have to wait.
  • The panel assembled by President Donald Trump to confront the pandemic has been sharply curtailed while the White House looks ahead to reopening.
  • Requiring patients to visit a hospital, clinic, or medical office to get an abortion pill is needlessly risking their health during the COVID-19 pandemic, a group of physicians allege in a lawsuit that seeks to suspend the federal rule.
  • Organizers canceled the Boston Marathon for the first time in its history, ending a 124-year run that had persisted through two World Wars, a volcanic eruption and even another pandemic.
  • Even as the pace of new infections quickens — with nearly 700,000 new known cases reported in the last week after the pathogen found greater footholds in Latin America and the Gulf States — many countries are sputtering into reopenings at what experts fear may be the worst time. In South Korea, more than 500 schools closed again as the country moves to stamp out a resurgence of the coronavirus in the capital, Seoul, and its surrounding metropolitan area.
  • A New York Times reporter and photographer are driving more than 3,700 miles to document life as Europe reopens, where surreal moments now seem normal, and normality surreal.
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