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The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know

Updated 25 June 2021

Updated 25 June 2021, pursuant to updated interim recommendations 

WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has issued its policy recommendations for the rollout of  the first COVID-19 vaccine approved for emergency use, the Pfizer-BioNTech COVID-19 vaccine.

According to SAGE, the Pfizer-BioNTech COVID-19 mRNA vaccine is safe and effective. The priority is to start vaccinating health workers at high risk of exposure, followed by older adults, before immunizing the rest of the population. 

Who should be vaccinated first?

While vaccine supplies are limited, it is recommended that priority be given to health workers at high risk of exposure and older people, including those aged 65 or older.

Countries can refer to the WHO Prioritization Roadmap and the WHO Values Framework as guidance for their prioritization of target groups.

Who else can take the vaccine?

The vaccine has been found to be safe and effective in people with various conditions that are associated with increased risk of severe disease.

This includes hypertension, diabetes, asthma, pulmonary, liver or kidney disease, as well as chronic infections that are stable and controlled.

Further studies are required for the impacts on immune-compromised persons. The interim recommendation is that immune-compromised persons who are part of a group recommended for vaccination may be vaccinated, though when possible, not before receiving information and counselling.

Persons living with HIV are at higher risk of severe COVID-19 disease. Limited safety data exists on HIV-infected persons with well controlled disease from the clinical trials. Known HIV-positive vaccine recipients should be informed, and when possible, counselled in relation to the available data.

Vaccination can be offered to people who have had COVID-19 in the past. But given the limited vaccine supply, individuals may wish to defer their own COVID-19 vaccination for up to 6 months from the time of SARS-CoV-2 infection.

Vaccine effectiveness is expected to be similar in lactating women as in other adults. WHO recommends the use of the vaccine in lactating women as in other adults. WHO does not recommend discontinuing breastfeeding because of vaccination.

Should pregnant women be vaccinated?

WHO recommends the use of the COVID-19 vaccine in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks. To help pregnant women make this assessment, they should be provided with information about the risks of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant women. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination.

Who should not take the vaccine?

People with a history of severe allergic reaction to any component of the vaccine should not take it.

There are currently no efficacy or safety data for children below the age of 12 years. Until such data are available, individuals below 12 years of age should not be routinely vaccinated.

Is this vaccine recommended for adolescents?

A Phase 3 trial in children aged 12-15 years showed high efficacy and good safety in this age group, leading to an extension of the previous age indication from 16 years onwards down to age 12 onwards.

Evidence suggests that adolescents, particularly older adolescents, are as likely to transmit SARS-CoV-2 as adults. WHO recommends that countries should consider using the vaccine in children aged 12 to 15 only when high vaccine coverage with 2 doses has been achieved in the high priority groups as identified in the WHO Prioritization Roadmap. 

Children 12-15 years of age with comorbidities that put them at significantly higher risk of serious COVID-19 disease, alongside other high-risk groups, may be offered vaccination. 

What is the recommended dosage?

A protective effect starts to develop 12 days after the first dose, but full protection requires two doses which WHO recommends be administered with a 21 to 28-day interval. Additional research is needed to understand longer-term potential protection after a single dose. It is currently recommended that the same product should be used for both doses.

Studies have shown a high public health impact where the interval has been longer than that recommended by the EUL. Accordingly, countries facing a high incidence of COVID-19 combined with severe vaccine supply constraints could consider delaying the second dose up to 12 weeks in order to achieve a higher first dose coverage in high priority populations. 

Is it safe?

WHO granted the Pfizer BioNTech vaccine EUL on 31 December 2020. WHO has thoroughly assessed the quality, safety, and efficacy of the vaccine and has recommended its use for persons above the age of 16.

The Global Advisory Committee on Vaccine Safety, a group of experts that provides independent and authoritative guidance to WHO on the topic of safe vaccine use, receives and assesses reports of suspected safety events of potentially international impact. 

How efficacious is the vaccine?

The Pfizer BioNTech vaccine against COVID-19 has an efficacy of 95% against symptomatic SARS-CoV-2 infection.

Does it work against new variants?

SAGE has reviewed all available data on the performance of the vaccine in tests to assess efficacy against a variety of variants. These tests indicated that the vaccine was effective against virus variants.

SAGE currently recommends the use of the Pfizer BioNTech vaccine according to the WHO Prioritization Roadmap, even if virus variants are present in a country. Countries should assess the risks and benefits taking into consideration their epidemiological situation.

Preliminary findings highlight the urgent need for a coordinated approach for surveillance and evaluation of variants and their potential impact on vaccine effectiveness. As new data become available, WHO will update recommendations accordingly. 

Does it prevent infection and transmission?

There is currently no substantive data are available related to impact of Pfizer BioNTech vaccine on transmission or viral shedding.

In the meantime, we must maintain and strengthen public health measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds, and ensuring good ventilation

What about other vaccines being developed to fight COVID-19?

WHO does not usually make vaccine specific recommendations, issuing instead one recommendation that covers all vaccines for a given disease, unless the evidence suggests a different approach is required.

Due to the large variety of COVID-19 vaccines based on very different platform technologies, WHO is looking at vaccines as they are authorized by highly competent national regulatory authorities and that are available in sufficient supply to address the needs of many countries.

WHO has no preferred product, and the variety of products, including their specific attributes and handling requirements, allow for countries to find the products that are most suitable for their circumstances.

WHO’s SAGE is expected to review other vaccines in the coming months. 

This webpage was updated on 20 April 2021 to ensure consistency of information and formatting.

This article was corrected on 12 January 2021 to remove an erroneous reference relating to pregnancy. WHO does NOT recommend that pregnancy be avoided post-vaccination.