The UK on Wednesday became the first country to approve AstraZeneca’s vaccine for emergency use. The company has reportedly increased production, with the goal of producing 2 million doses per week.
Although the drugs were approved for emergency use, they haven’t finished clinical trials, the government said. Phase 3 trials for Bharat’s drug, Covaxin, are underway with about 20,000 volunteers in 26 hospitals, said Suchitra Ella, Bharat’s joint managing director, in a televised interview with Rajya Sabha TV on Friday.
With a population of 1.3 billion people, India is the world’s second-most populous country. It plans to vaccinate 300 million people by July, according to Gulf News. That will include 30 million healthcare and frontline workers.
The country has been hard hit by COVID-19. About 149,435 people have died from it in India, according to figures from the Ministry of Health and Family Welfare.
With 10.3 million confirmed cases, it’s behind only the US’s 20.4 million cases, according to data compiled by Johns Hopkins University.
Like elsewhere, rumors have spread about vaccine side effects. In India, some worried the vaccine would make people impotent, a falsehood Somani sought to end on Sunday.
“Some side effects like mild fever, pain & allergy are common for every vaccine. [The impotence rumour] is absolute rubbish,” he said, according to the Times of India.
After the emergency approval announcement, Modi thanked frontline workers for their work battling COVID-19.
“We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives,” he said.
Jonathan Howard is a neurologist who works at Bellevue Hospital in New York City. During the pandemic, he transitioned to leading a team of healthcare workers tending to COVID-19 patients.
Howard says he jumped at the chance to join the AstraZeneca vaccine trial, as he’s had a long-held fascination with vaccines and the anti-vaccine myths that surround them.
Howard explains that although the COVID-19 vaccines were developed this year, years of work had already been done on the safety and efficacy of the same type of vaccine, so scientists weren’t starting from scratch.
While there’s still more to learn about how the vaccines will work when distributed to millions of people, Howard says we may even find out the vaccines have unexpected benefits, just as others have in the past.
As a neurologist who specializes in treating multiple sclerosis, vaccines and vaccine-preventable diseases do not play a significant role in my professional career. Although I’ve seen polio and measles, the only vaccine-preventable disease that I routinely saw pre-COVID-19 was shingles.
When the first wave hit New York City, I planned on staffing Bellevue Hospital’s neurology consult service. Though some patients suffered catastrophic strokes, overall it was relatively quiet from a neurological perspective and there was little for us to do. As others marveled, it seemed like every other disease vanished for a month during the COVID-19 spike. As cases picked up, I transitioned to running on a floor team taking care of COVID-19 patients. All of the regular clinic patients were moved to video visits.
To be honest, there was not a great deal to do for most COVID-19 patients beyond giving them oxygen and hope for the best.
We would do our rounds, offer what we could to make them comfortable, and encourage them to lie in the prone position, as there is some evidence that this can help breathing. I also made sure that no patient on my team received any experimental treatments (such as hydroxychloroquine). Doing “nothing” is often very difficult for doctors, but is preferable to giving out unproven treatments unless patients are clearly dying or in a clinical trial. If patients were getting better, we would discharge them. If they were deteriorating, we would send them to the ICU. Not infrequently, we would return in the morning to learn that a patient had passed during the night.
I was honestly the most stressed just before the pandemic arrived, with frequent nightmares of patients dying in the hallways and streets. I started taking a medication to help me sleep for the first time. While such scenes did occur at some hospitals, our emergency room was relatively quiet on most days and the vast majority of our patients were transferred from other hospitals, thus largely avoiding chaos. Still, the hospital intercom was the busiest I’ve ever heard it, with calls for the “airway team” blaring throughout the hospital every five minutes it seemed. I saw patients as young as 23 die alone, with no one by their side.
I was also worried about my own health and the health of my team.
It turns out PPE works really well and most healthcare workers who contracted COVID-19 did so at home or from other healthcare workers in workrooms or cafeterias. However, this was not clear during the early stages of the pandemic, and like all healthcare workers, I wondered if I was bringing home a deadly virus to my family.
I’ve had a fascination with vaccines and people who oppose them ever since a former colleague of mine inexplicably turned against vaccines. This motivated me to learn more about vaccines and the myths that surround them. I even authored a chapter on the anti-vaccine movement in a book about pseudoscience.
Having argued for years that vaccines are properly tested, I jumped at the chance to participate in a vaccine trial myself. I’ve always believed that people who participate in medical research are doing a noble thing. If no one volunteered for such research, medicine would never advance.
I received my first shot of the vaccine or placebo at Bellevue Hospital in mid November.
Although I work at Bellevue Hospital, I still had to enroll in the study by filling out a general online form for people interested in participating in vaccine trials. I was sent information about the trial and what to expect on the first visit.
My experience has been pretty boring so far, which is of course good news. My first visit on November 19 lasted just over an hour. I had a complete medical history and physical exam, which fortunately for me was quite brief. I was tested for COVID-19, given some snacks, and then received the shot.
Although I of course don’t know whether I got the real vaccine or a placebo, I am fairly certain I got the real thing.
I woke up the next day feeling pretty rotten: I had a sore arm, a low-grade fever, muscle aches, and a headache. This lasted for about 24 hours, except for the sore arm, which lasted for a few days. Considering the horrors I witnessed during New York’s surge, this was a minuscule price to pay for the end goal of developing a COVID-19 vaccine.
I’ll be going to get my second dose on December 18. In the meantime, I have to check in weekly via an online questionnaire to see if I have any symptoms. Staff is available to me 24/7 if I have any questions or problems.
Though I am fairly confident I have some protection against COVID-19, I have not changed my behavior at all. I am not perfectly certain I received the real vaccine and I have yet to get the second dose. Even after this, I will continue to be cautious. No vaccine is perfectly effective, and it is possible that the vaccines will prevent people from getting sick themselves, but not from spreading the disease to others.
The AstraZeneca trial I’m in is a Phase 3 trial, which are the largest trials that determine whether a vaccine is truly safe and effective.
However, even before the vaccine got into my arm, years of work had been done on the safety and efficacy of this type of vaccine. The AstraZeneca vaccine is an adenovirus-based vaccine that uses a harmless, modified cold virus to induce an immune response against SARS-CoV-2, the virus that causes COVID-19. Overall the vaccine appears to be about 70% effective, though unexpectedly, a lower-dose of the vaccine appears more effective than a higher dose. It’s unclear why this might be and needs to be confirmed in larger studies.
It’s also a relatively inexpensive vaccine (less than $4 per dose) and does not need to be stored at extremely low temperatures. Overall research into vaccines for coronaviruses has been going on for years, and a vaccine using the same technology has previously been approved for Ebola. So, scientists were fortunately not starting from scratch in designing these vaccines – another reason progress was so rapid this year.
Even when the Phase 3 trials are done, we’ll still have a lot to learn about them.
Though they appear very effective in clinical trials so far, we’ll have to see if this holds up in the “real-world.” While the vaccines are highly effective in preventing disease, no one knows if people can remain asymptomatic carriers, spreading the disease to others. No one knows yet if the vaccine will confer lifelong immunity or if boosters may be needed on a periodic basis.
Additionally, rare side effects may only be revealed once a vaccine has been given to millions of people, though determining causality is difficult outside of a controlled trial. After all, if we gave 100 million people a cookie, unexpected negative side effects or reactions would likely happen to some of them.
We may also learn that the COVID-19 vaccines have unexpected benefits. The measles vaccine, which has been around since the 1960s, was recently shown to confer protection against other infectious diseases.
Given these unknowns, anyone who gets a COVID-19 vaccine will be contributing to medical research in some way. And of course, we will certainly be learning about the long-term side effects of COVID-19 itself for many years. Many survivors will have their lives permanently altered by this virus.
Overall, I’m very optimistic about 2021 and that by the summer or fall, we should have a gradual return to normal.
The completion of multiple successful trials for a new virus in under a year is undoubtedly one of the greatest scientific achievements in the history of medicine. The hardest part might be getting the vaccine delivered to people around the world and convincing them to take it. Still, I am beyond proud to have played a small role in this project.
Jonathan Howard is an associate professor of neurology and psychiatry at the NYU Langone School of Medicine and a neurologist at Bellevue Hospital. Follow him on Twitter.