An acquaintance posted some skepticism of the new Covid-19 vaccines, and I as a physician I felt compelled to respond. It took some time, I had to dive deep into the data provided by the studies and the independent review of the studies. Here’s the gist of my response.
I understand the concerns about a new vaccine that has not had the benefit of a test of time and broad distribution. As a physician, I’m not usually one to jump on the bandwagon for new medications. I, too, like to see how it plays out once released to the greater community before recommending it to my patients.
But in this particular case, we have an emergency the likes of which we have not seen in 100 years, one in which 3,000 people are dying a day in this country, in which the economy is strained and people are in desperate financial situations, in which our hospitals and doctors are overtaxed. There is nothing like needing to put someone on a ventilator but not having the medication needed to paralyze them or sedate them because of short supplies, so you cannot give them what they need to live. So if there is something that shows promise, but may have risk (that has NOT been demonstrated so far), I will make exceptions.
As for the safety and efficacy of the currently released vaccines, I’ve summarized here the data from the Pfizer studies, which were reviewed by an INDEPENDENT advisory committee (not beholden to the company, the FDA, or the CDC).
The Pfizer study enrolled 43,000 people. About ½ got placebo and ½ got vaccine. It is NOT the case that the trial participants were all ‘young healthy people’. 7000 of them were over 65 yrs old, 924 over 75 yrs old. 6,556 were ‘obese’ (BMI >30, known to be a group at higher risk of severe Covid disease). Several thousand had underlying medical conditions, making them ‘high risk’ for severe infection. And while ‘severe covid or death’ were not defined endpoints in the study, there is data on that that did come out of the study, as shown below.
Some say the most that can be said of the vaccine is that it can allow the vaccinated person to become an asymptomatic spreader rather than a spreader with symptoms. This is not the case. There is no evidence (either way) that those vaccinated became ‘asymptomatic spreaders’. Yes, it would have been very interesting to have data on how many of the vaccinated subjects tested positive using a nasopharyngeal DNA test, which could give us an idea if people could possibly be spreading the disease. But even if they did test positive, it stands to reason the fact that they would not be coughing and breathing heavy with symptoms suggests they would not spread the disease as much.
On the other hand, it is true that getting the vaccine could give someone a false sense of security. So yes, maintaining social distancing precautions and wearing masks will continue to be important until the pandemic is under control.
Of the 18,198 who got vaccine, 8 people got infected, as compared with 162 of the 18,325 who got placebo.The results were roughly equal among different age groups, races, ethnicities, and patients with different risk factors. They saw the same results among people who had pulmonary disease, diabetes, obesity, cardiovascular disease and cancer. Those are pretty good results, up there with the efficacy of the MMR vaccine and the new Shingarix shingles vaccines.
More importantly we DO have data suggesting that the vaccine can prevent severe disease/death. This information wasn’t an ‘endpoint’ in the study design, but of those vaccinated, only ONE person suffered from severe disease, as compared with NINE among those who got placebo. While the numbers were not adequate to draw strong conclusions, there seems to be a signal that the vaccines protect against severe disease.
Here is a graph showing the efficacy. Note the separation of the curves at week 2. X axis is time, Y axis is number infected. Blue is the placebo group. Red is the vaccinated group. The curves stay close in the first two weeks, then there is a significant divergence, demonstrating the efficacy of the vaccine. There were hardly any new cases in the vaccinated group after 2 weeks. The curves look pretty impressive.
In terms of side effects, the study participants who got the vaccine reported a higher incidence of some sort of systemic reaction, such as fatigue, headaches, chills, diarrhea swollen lymph nodes or fever, especially after the second dose, as compared to the placebo group. This is not surprising, as the entire purpose of the vaccine is to cause an immune response. Very few reported that they needed to alter their normal activities (work or exercise) due to the side effects. The side effects came up in the first 24 hours, and lasted 24 to 48 hours for the most part.
Admittedly, we don’t know what we don’t know. The studies only report on 2 months of events. We do not have good information as to whether the vaccine protects against viral shedding, which is all important because preventing viral shedding is how we are going to protect people who cannot or will not get the vaccine, and how we will develop herd immunity. On the other hand, if we can prevent illness, and severe disease, it stands to reason that we can prevent the spread, and limit the hospital admissions, where the system is most strained right now.
And we don’t have information about long-term safety. 44,000 subjects is not enough to uncover a one in a million side effect. But our current rate of infection and SEVERE infection is more than one in a million. And now that hundreds of thousands of doses are being administered, we will have more data soon. Anyone getting the vaccine is encouraged to sign up for V-Safe, a mobile app that collects data on side effects. Those getting the vaccine (healthcare workers) are exactly the kinds of people who will report to that database, whether they have symptoms or not.
The bottom line is that the vaccine seems to be safe for the large majority or recipients, certainly safer than getting a case of Covid. And it clearly is effective, at least at the two-month mark, at preventing disease. I’ll take my chances with the vaccine over the chance of getting severely ill with disease.
Stay safe. Stay healthy.