Moderna’s coronavirus vaccine has started a nationwide, Phase 3 trial

The CDC also updated its guidelines for how long people must self-isolate after testing positive for COVID-19.
Pink face masks.
The number of positive case counts of COVID-19 continues to surge in southern and southwestern states. Pixabay

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As the dog days of summer are upon us, cases of COVID-19 are still climbing in most states across the country. Deborah Birx, the White House’s emergency response coordinator, told reporters in Frankfort, Kentucky yesterday that federal health officials are advising any states with increasing COVID-19 cases to close bars and limit indoor dining in restaurants. The novel coronavirus has been found to spread via aerosol droplets, making the crowded indoor spaces with limited ventilation highly risky for spread. Birx also noted that social gatherings should be limited to 10 people in those states, and that everyone should be wearing masks in public places where people cannot properly social distance. Many areas around the country and world are seeing new outbreaks and health officials are still debating the safest approach for schools to reopen this fall. Further, drug companies are still pressing forward with their race for an effective vaccine. Here’s the most important news of the week.

Moderna Therapeutics started a late-stage trial of its coronavirus vaccine this week

The pharmaceutical company Moderna Therapeutics, based in Cambridge, Massachusetts announced this week that it has started phase three trials of its COVID-19 vaccine candidate. Phase three is the last main phase of testing a vaccine to prove it’s safe and effective against the virus. The National Institutes of Health partnered with Moderna on this venture.

This phase involves giving the vaccine to 30,000 healthy people in 89 designated testing locations across the country. The protocol is double blind, meaning that half the study’s subjects will get the vaccine while the other half will receive a saltwater placebo—and neither the participants nor the physicians involved will know who is getting what.

The goal is to determine whether the vaccine effectively prevents people from getting coronavirus. More specifically, the researchers want to know if it stops people from getting the virus at all, or if it just prevents the worst bouts of the disease. Another question is if it’s like the flu shot, where you can just get it once and be safe, or if you need multiple doses like Gardasil, which protects against cervical cancer.

The vaccine contains a synthetic segment of coronavirus’s genetic material called messenger RNA. When it enters the body, our immune systems see it as an invader, generates an immune response, and remembers how to attack it if the virus ever reappears.

If it proves successful, this will be the first messenger RNA-based vaccine to gain FDA approval. Messenger RNA-based vaccines are becoming increasingly popular in research development. They involve producing only a synthetic component of the virus rather than whole microbes or an attenuated or live virus; this makes them easier to produce on a massive scale. Because this is an entirely novel virus, no one, except potentially those who have gotten the virus already, is immune to SARS-CoV-2. To control the outbreak both nationally and internationally, pharmaceutical companies need a vaccine that can be easily produced in massive quantities. On Sunday, the drug company announced it has received $472 million from the U.S. government to aid in the development of its vaccine.

People who test positive for COVID-19 can return to work after 10 days if they are symptom-free, according to new guidelines from the CDC

Last Wednesday, the Centers for Disease Control and Prevention updated its guidance on when people who tested positive for COVID-19 can return to work. Taking into account the most up-to-date evidence for how long the virus stays in the body, the CDC says that people who have “mild to moderate” cases of the novel coronavirus can return to work within ten days of when their symptoms started.

The CDC says studies show that the concentrations of viable SARS-CoV-2 (the virus that causes COVID-19) particles decline rapidly after the onset of symptoms. In fact, studies show the time people are most infectious and spread the disease most widely is in the days prior to the onset of symptoms, partially because they might not know they have the virus.

Previously, the United States, as well as other countries like China, have relied on negative tests to estimate when someone can leave isolation and return to work. But with better data and the fact that test results in the US can often take weeks, this protocol is far less practical. Some research even suggests that dead, noninfectious, viral fragments may linger in people for a long time after a person’s symptoms clear up but may trigger a positive test result.

Florida has now surpassed New York state in total coronavirus cases

Once the U.S. epicenter for coronavirus cases, New York state has been able to significantly lower infection rates. As of Sunday, Florida has now surpassed New York in total coronavirus cases, according to The New York Times. The state of Florida now has at least 423,847 cases; New York state reached 416,000 reported cases.

Florida has seen a rapid increase in COVID-19 cases over the past few weeks, particularly among young people. According to data from the Florida Department of Health, more than a third of reported coronavirus cases are among people aged 15 to 34. Researchers are worried this age bracket could shift in the coming weeks to older, more at-risk, folks who make up a significant portion of the state’s population.

COVID-19 testing still takes too long to be truly useful

Proper testing is a key component in controlling COVID-19 cases. But that testing must be done in a timely fashion to make a difference. In an interview last week with CNN, Brett Giroir, the assistant health secretary who oversees the government’s national coronavirus testing response team, acknowledged that while testing levels have been adequate in most places, turnaround times for results have been lagging. As The New York Times points out, when these turnaround times are too delayed, the results could be useless to the individual who took the test and don’t contribute to the overall public health response to the virus.

Part of the reason for these delayed results could be due to a supply shortage. In particular, disposable, tiny pipette tips are used during every testing procedure but are currently hard to come by, as are the chemicals used to conduct the tests.

Coronavirus cases continue to climb, both nationally and worldwide

In the past two weeks, nearly twice as many countries have reported a significant jump in new coronavirus cases. Early on in the pandemic only a handful of regions around the world—Wuhan, China, Italy, Spain, New York, and Iran—experienced significant outbreaks. Those areas started to level off in April after extreme social distancing measures were put in place. However, as areas around the world, including those that weren’t part of the initial outbreak, began to open up their economy, outbreaks of COVID-19 started reappearing and in new areas. In the United States that can be seen in regions in the southwest like Houston and other parts of the south like Florida and South Carolina. Around the world, countries like Brazil, Colombia, and South Africa are experiencing major spikes in coronavirus cases for the first time. To see if your state or country is experiencing an outbreak, check out this graphic.