What to Know About the Covaxin COVID-19
Vaccine's Side Effects
The adverse effects of the Covaxin COVID-19
vaccine, as well as the controversies surrounding its emergency use
authorization, are discussed in this Snapshot feature.
Bharat Biotech, an Indian biotechnology company,
and the Indian Council of Medical Research produced Covaxin, a COVID-19
vaccine.
According to interim phase 3 clinical data, it's
a two-dose vaccine with a 78 percent efficacy rate.
On January 3, 2021, India's drug regulatory
authority, the Central Drugs Standard Control Organization, approved the
vaccine for emergency use. People aged 18 and up can now be vaccinated with it.
Bahrain, Botswana, Iran, Mexico, Nepal, the Philippines, Vietnam, Paraguay,
Zimbabwe, Guyana, Trinidad & Tobago, and Mauritius are among the 12
approved vaccines for emergency use.
Covaxin, also known as BBV152, is an inactivated
vaccine, a form of whole-virus vaccination. A modified or dead version of the
virus, in this case, SARS-CoV-2, is included in an inactivated vaccine, which
cannot replicate and so cannot cause sickness.
The virus is an inactivated vaccine that works
by triggering the immune system and causes the body to produce antibodies,
preparing it to fight infection in the future.
Common side effects
The vaccine's main adverse effects, according to
the Indian government's Ministry of Health and Family Welfare (MoHFW), are:
- fever
- headaches
- irritability
- pain, swelling, or both at the site of injection
These side effects overlap with those of other
currently available COVID-19 vaccines. They are expected to last for a few
days.
According to the data, other documented side
effects in the vaccine's phase 1 and 2 clinical studies include fatigue, body
aches, nausea, vomiting, and chills. There were no significant adverse effects
noted.
Seventeen participants, or 4.5 percent, suffered
injection-related reactions, and 23 participants, or 6.1 percent, reported
systemic reactions, such as body pains and fever, after receiving the initial
dose of the vaccine at a concentration of either 3 or 6 micrograms. After the
second dose, a similar number of adverse responses were recorded.
MoHFW recommends taking paracetamol, often known
as acetaminophen (Tylenol), to relieve some of these mild adverse effects.
Allergies and other contraindications
According to Bharat Biotech's vaccine fact
sheet, a severe allergic reaction to Covaxin is scarce, but it is possible.
A severe allergic reaction, according to the
fact sheet, might cause the following symptoms:
- breathing difficulties
- swelling of the face and throat
- a fast heart rate
- rashes all over the body
- dizziness
- weakness
The vaccine has a contraindication for people
with a history of allergies. However, the sheet does not specify whether this
is all-encompassing or applies only to people with allergies to the vaccine’s
ingredients.
Anyone with a bleeding issue and anyone pregnant
or breastfeeding should not receive the vaccine, according to the fact sheet.
According to the MoHFW website, Covaxin does not
affect fertility, and such claims are false. There were similar rumors about
the measles and polio vaccines, which, according to studies, did not affect
fertility.
Controversy about approvals
The speed with which Covaxin's emergency use
authorization was issued has generated mixed responses.
The vaccine's authorization has been criticized
by two scientific communities, the All India People's Science Network and the
All India Drug Action Network, with the latter citing "intense concerns
arising from the absence of efficacy data."
The New Indian Express, on the other hand, said
that a group of 45 scientists and medical experts signed a statement claiming
that the critics' "irresponsible comments of vested interests" are
politically driven and threatening the research's credibility.
"This vaccine is a full virus inactivated
vaccine," according to the experts, "which may [provide] better
protection, even against mutant strains of the virus, because the immune
response will be against several antigens rather than just against [the] spike
protein."
The vaccine's efficacy will be further investigated after a final analysis of phase 3 clinical trial data is complete in June.
