A Covid-19 Vaccine by Election Day is Possible But Unlikely

A Covid-19 Vaccine by Election Day is Possible But Unlikely

Ayden Nguyen, Writer

The United States Center for Disease Control and Prevention(CDC) is telling states to be prepared to distribute a Covid-19 vaccine by as early as next month. The Food and Drug Administration(FDA) has informed the public that President Trump has been pressuring agencies to produce a vaccine so he can have a successful vaccine by election day. But is it possible that we can produce a reliable vaccine by November?

 

Doctors who are running the trials say no. “Do the simple math,” says Dr. Larry Corey, “We designed the trial to get to 130, 140 endpoints(coronavirus infections) seven months from starting the trial, and the first one started in mid-July.” What Dr. Corey is trying to imply is that the trials were designed so that it would persist until 140, 150 people got the infection. Then researchers would look to see if less people who got the real vaccine were among those people. The only problem is, 7 months from July would be February 2021. However, if you have a highly effective vaccine and there is a high rate of infections in the volunteers who received the placebo, you could get a vaccine earlier. “If you had a highly effective vaccine, maybe you would find that in 5 months from designing the trial,” Corey said. But 5 months from July would still be December.

 

There are other obstacles that would delay the vaccine. These include not enough volunteers and time of dosage. The trials were designed to have 140-150 endpoints and the designers think they need 30,000 people for each trial to get to the goal. Also, because there are not enough volunteers, people have not received their first dosage yet. Dosages must be taken one month apart. This means if you get your vaccine this month, you have to wait until next month to get the next dosage. “Then you have to wait 2 weeks for full immunity,” says Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

 

If it is not logical to have a vaccine by election day, why are certain organizations planning to have one by then? Dr. Ann Falsey states that, “It’s highly unlikely, but it is theoretically possible without doing anything nefarious.” For example if the virus is spreading fast you would get a lot of data very fast. “Unfortunately, there may be a real hotspot and there may be a lot of activity,” Dr. Falsey says. So you could possibly get a vaccine sooner than expected but it is highly unlikely. 

 

Dr. Offit agrees. The trials are not designed to detect people with no symptoms or have mild symptoms. “The clinical endpoint is a severe disease,” he said. This makes it less likely to have surprise data. Additionally, the FDA requires any vaccine to be 50% effective before the vaccine could be considered. This now means that at least 50% of volunteers cannot get the virus. In addition,during the trials, volunteers are still advised to keep safety precautions. “You are telling people to wear face masks and social distance,” Offit says, “You are not telling them to go to a maskless biker’s convention in South Dakota. You want them to protect themselves.”

 

Normally, the FDA takes about a year to approve a vaccine after phase 3 results have been found and submitted. An accelerated process would take about 10 months. In the case of a pandemic, the process is accelerated and the organizations take action to get a vaccine out as soon as possible. This includes ordering syringes and other equipment before trials are over so that organizations can be prepared to distribute the vaccine. But, the only way we could get a vaccine to be considered, we need surprising data from at least one of the trials. CEO and Chairman of Pfizer, Dr. Albert Bourla, thinks that could happen. His phase 3 clinical trials have enrolled around 23,000 volunteers and some are already receiving the second dose of vaccine. According to Bourla, Pfizer should have enough results to determine the effectiveness of the vaccine by the end of October.

 

The people making these decisions are an independent group called the Data and Safety monitoring board(DSMB). “They are there to protect the safety and to define the accuracy of the vaccine,” Corey said. If the DSMB sees a clear signal that the vaccine is unsafe, they can stop the trials. They can also stop the trials if the vaccine has no effect on the people. Additionally, they can stop the trials if the vaccine is performing better than expected. This is why the CDC wants to distribute the vaccine by October or November says Health and Human Services Secretary Alex Azar.

 

“God forbid we get great data and it comes out of the Data and Safety Monitoring Board and the FDA finds that it meets their standards, and we aren’t ready to distribute,” Azar said, “We need to be ready for all contingencies and that’s why the CDC is doing this.” Corey says that he doubts that the DSMB would be pressured to stop a trial and recommend a FDA review just because of pressure – whether it is political pressure or the pressure of trying to end a global pandemic. “It’s not like they don’t understand the responsibility. All of them know how to read,” Corey said. Doctors Falsey and Offit both agree with Corey. “I don’t think that the message is that we are going to look at the data in the middle of the trial and if it looks kind of good, we’ll go with it,” Falsey said. If a vaccine gets sped up, it will because there is certain evidence that the vaccine works she claims.

 

Offit says he trusts the FDA and the authorization of the vaccine. But not everybody does.“The irony of this is you may, by the end of the year, have a safe vaccine. But you have an administration that hasn’t garnered a lot of trust,” Offit said, “Maybe we will have a safe and effective vaccine but people still won’t trust it because they don’t trust the way the administration has handled science. That would be the ultimate irony.”