HEPATITIS B VACCINE

Background and Date of Approval

Hepatitis B Vaccine contains Hepatitis B Injection (rDNA) as its active agent. It is used to protect against hepatitis B virus infection in children. This vaccine also protects children from hepatocellular carcinoma. Hepatitis B virus damages the liver and gradually impairs liver function. Hepatitis B Vaccine is particularly suitable for children with neurological disorders. This vaccine enables normal immunisation in preterm and low birth weight infants, for whom immunisation might otherwise be delayed. The first hepatitis B vaccine received approval from the US Food and Drug Administration (FDA) in 1981. Since then, several vaccine formulations have been developed and approved by the FDA for use in the United States. The most recent approval occurred in November 2017, when the FDA approved HEPLISAV-B, a two-dose hepatitis B vaccine for adults.

Uses

Hepatitis B Vaccine is used to prevent Hepatitis B virus infection.

How is it administered?

The Hepatitis B Vaccine is administered as an injection into the upper arm. The specific dosage and number of injections required can vary depending on the individual's age and vaccination history. For infants, the vaccine is typically given in three doses, with the first dose administered at birth or shortly after that and the second and third doses given at 1-2 months and six months of age.

Side Effects

The hepatitis B vaccine is generally considered safe, with most people experiencing no or only mild side effects. Common side effects may include pain, redness or swelling at the injection site, headache, fever, fatigue, and muscle aches. Serious side effects such as severe allergic reactions and neurological disorders are rare.

Warnings

Rare instances of severe allergic reactions and neurological disorders have been reported with the hepatitis B vaccine. Individuals who are pregnant or have weakened immune systems should discuss the risks and benefits of vaccination with their healthcare provider. Other warnings include the possibility of fainting, shoulder injury related to vaccine administration, and the potential for the vaccine to interact with other medications.

Precautions

Individuals with a history of severe allergic reactions to any Hepatitis B Vaccine component should not receive it. A person should disclose medical conditions or allergies to a healthcare provider before receiving the vaccine. After vaccination, it is recommended to remain at the healthcare facility for some time to monitor for any immediate adverse reactions and to report any delayed or persistent symptoms to your healthcare provider.

Word of Advice

Before receiving the Hepatitis B Vaccine, patients should be aware of potential risks and warnings. Pregnant patients and those with weakened immune systems should discuss the risks and benefits of vaccination with their healthcare provider. The vaccine may be less effective in patients with weakened immune systems, including those with HIV or those undergoing chemotherapy. Vaccination remains the important means of preventing hepatitis B infection and associated liver diseases, and the benefits of protection outweigh potential risks.

References

Bharat Biotech, [Revised on July 2019] [Accessed on 9th May 2023], https://www.bharatbiotech.com/images/revac-b-mcf/Revac-B-mcf-Package-Insert.pdf GlaxoSmithKline, Electronic medicines compendium (EMC), [Revised on May 2020] [ Accessed on 9th May 2023], https://www.medicines.org.uk/emc/files/pil.1637.pdf KD Tripathi, Essentials of Medical Pharmacology, Vaccines and sera, 7th edition, 2013, 923.

Frequently Asked Questions

Can I get the Hepatitis B Vaccine if I have already had hepatitis B in the past?

Yes, you can still receive the Hepatitis B Vaccine if you have had hepatitis B. The vaccine can provide additional protection against future infection and is recommended for individuals at risk of contracting the virus.

Is the Hepatitis B Vaccine required for travel to certain countries?

Yes, some countries require proof of hepatitis B vaccination as a condition of entry. It is important to check the requirements of your destination country and obtain the necessary vaccinations and documentation well before your travel dates.

Can the Hepatitis B Vaccine be given to infants?

Yes, the Hepatitis B Vaccine is recommended for infants and is typically given in three doses over the first six months of life. Infants born to mothers who are infected with hepatitis B are especially recommended to receive the vaccine.

Can the Hepatitis B Vaccine cause me to test positive for hepatitis B?

No, the Hepatitis B Vaccine cannot cause you to test positive for hepatitis B infection. The vaccine contains only a small piece of the virus's surface protein, insufficient to cause infection or trigger a positive test result.

Do I still need to get the Hepatitis B Vaccine if I have already been diagnosed with liver disease?

Yes, individuals with liver disease may be at increased risk of complications from hepatitis B infection and are recommended to receive the vaccine. However, discussing the risks and benefits of vaccination with your healthcare provider based on your health status is important.

Can the Hepatitis B Vaccine protect me from all types of hepatitis?

No, the Hepatitis B Vaccine only protects against the hepatitis B virus. There are other types of hepatitis, such as hepatitis A, C, D, and E, that are caused by different viruses and require separate vaccines or treatments.

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS