The Drugs Controller General of India (DCGI) on Tuesday granted market authorisation to Serum Institute of India (SII) to manufacture an indigenously-developed vaccine against cervical cancer.
It further reported that DCGI's approval comes following recommendation by the Subject Expert Committee (SEC) on Covid-19 of Central Drugs Standard Control Organisation (CDSCO) on June 15 over the same.
This is the first indigenously-developed vaccine against cervical cancer in India. Cervical cancer ranks as the second most frequent cancer among women in the 15-44 years age group.
Here is all you need to know about cervical cancer, the vaccine, the significance of its development, and how it's expected to benefit recipients.
What is cervical cancer?
Cervical cancer is a type of cancer that takes place in cervix — the lower part of the uterus that connects to the vagina, according to Mayo Clinic.
It adds that it's not exactly known what causes cervical cancer, but human papillomavirus (HPV) definitely plays a role.
Healthline reports that most cervical cancer cases are caused by the sexually transmitted HPV.
It adds, "There are about 100 different strains of HPV. Only certain types cause cervical cancer. The two types that most commonly cause cancer are HPV-16 and HPV-18."
This means that being infected with HPV does not necessarily mean you have cervical cancer.
There are multiple screening and diagnostic methods to check for cervical cancers.
Screening methods:
1. In a pap test, the doctor scrapes and brushes cells from the cervix to be examined in a lab for abnormalities, according to Mayo Clinic. It can detect abnormal cells in the cervix, including cancer cells and cells that show changes that increase the risk of cervical cancer.
2. In HPV DNA test, cervix cells are tested for infection with any of the types of HPV that are most likely to lead to cervical cancer.
Once cancer is suspected or abnormalities are found, a screening test can be followed by a diagnostic test. Mayo Clinic lists following methods:
1. In punch biopsy, a sharp tool is used to pinch off small samples of cervical tissue.
2. In endocervical curettage, a small, spoon-shaped instrument (curet) is used or a thin brush is used to scrape a tissue sample from the cervix.
3. In electrical wire loop method, a thin, low-voltage electrified wire is used to obtain a small tissue sample — generally done under local anaesthesia.
4. The cone biopsy (conisation) is a procedure that obtains deeper layers of cervical cells for laboratory testing.
Healthline notes that many women don’t realise they have cervical cancer as it usually doesn't cause symptoms until it has advanced. It lists typical symptoms as:
- Unusual bleeding, like in between periods, after sex, or after menopause
- Vaginal discharge that looks or smells different than usual
- Pain in the pelvis
- Urinating more often
- Pain during urination
"As cancer progresses and spreads to nearby tissues and organs, you may experience pain in your pelvis or have issues urinating. Other people will feel generally unwell, tired or lose their appetite," notes Cleveland Clinic.
It lists the following symptoms when cervical cancer spreads to nearby tissues and organs:
- Diarrhoea, or pain or bleeding from your rectum when pooping.
- Dull backache or swelling in your legs.
- Pelvic/abdominal pain.
Cervical cancer treatment
Healthline lists four main treatments for cervical cancer:
1. In surgery, the objective is to remove as much of cancer as possible. The extent of the cells, tissues, or organs removed depends on the extent of cancer.
The UK National Health Service says only a part of the cervix is removed in case of very small cancer. In other cases, it says the cervix and upper part of the vagina is removed.
However, surgery might be extensive too depending upon the spread. The cervix and womb (hysterectomy) might need to be removed, which can include removing the ovaries and fallopian tubes. The UK NHS says in some cases, the cervix, womb, ovaries and fallopian tubes, and all or parts of the bladder, bowel, vagina or rectum are removed.
"This is only offered if the cancer has come back and other treatment is not possible," notes UK NHS.
2. Radiation therapy
Healthline explains that radiation kills cancer cells using high-energy X-ray beams, which can be delivered through a machine outside the body but can also be delivered from inside the body using a metal tube.
3. Chemotherapy
Chemotherapy uses drugs to kill cancer cells. Healthline notes that this treatment takes place in cycles as time is given to patient's body to recover between multiple cycles.
4. Targeted therapy
Bevacizumab is a new drug that blocks the growth of new blood vessels that help the cancer grow and survive, according to Healthline. It adds that this drug is often given together with chemotherapy.
Cervical cancer vaccine
Certain strains of human papillomavirus (HPV) can cause cervical cancer. The cervical caner vaccine works by targeting these viral strains.
The vaccine is effective at preventing cervical cancer if it's taken before you have had the virus.
The vaccine may be taken when you are 11-12 years old, according to US Centers for Disease Control and Prevention (US CDC).
It says, "Children ages 11–12 years should get two doses of HPV vaccine, given six to 12 months apart. HPV vaccines can be given starting at age nine years."
WebMD explains that it's suggested you take the vaccine early as it's best taken before you become sexually active. There is only cervical cancer vaccine in the United States.
Vaccination and regular cervical screening is the most effective way to prevent cervical cancer, said K Kaarthigeyan of PSG Institute of Medical Sciences and Research, Tamil Nadu, in a research paper published in the Indian Journal of Medical and Paediatric Oncology.
The Quadrivalent Human Papillomavirus vaccine (qHPV) made by the Serum Institute is India's first indigenously-developed vaccine against cervical cancer.
The Serum Institute's cervical cancer vaccine
Prakash Kumar Singh, Director (Government and Regulatory Affairs) at the Serum Institute of India (SII), had applied to the DCGI seeking market authorisation of qHPV after the phase 2/3 clinical trial was completed with support of the Department of Biotechnology, according to PTI.
It added that the government advisory panel National Technical Advisory Group on Immunisation (NTAGI) had recently also approved the qHPV after reviewing the clinical trial data of the vaccine.
PTI reported that In the application to the DCGI, Singh is learnt to have stated that qHPV vaccine CERVAVAC has demonstrated robust antibody response that is nearly 1,000 times higher than the baseline against all targeted HPV types and in all dose and age groups.
In the application, Singh had mentioned that lakhs of women are diagnosed every year with cervical cancer as well as few other cancers and death ratio is also very high.
"Also, it is noteworthy that presently our country is fully dependent on foreign manufacturers for the HPV vaccine. In line with the philosophy of our group and under leadership of our CEO, Dr Adar C Poonawalla, it has always been our endeavour to make available high quality 'Made in India' vaccines at affordable price for people of our country and world at large," Singh mentioned in the application.
