Pfizer BioNTech COVID-19 vaccine: What you need to know

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The FINANCIAL —  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 notes.

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, according to WHO.

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.

The vaccine has not been studied in lactating women, but it is not a live virus vaccine, the mRNA does not enter the nucleus of the cell and is degraded quickly, so it cannot interfere with cell functions.

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If a lactating woman is part of a group (e.g. health worker) recommended for vaccination, vaccination can be offered. SAGE does not recommend discontinuing breastfeeding after vaccination. More evidence is being sought in order to further inform WHO’s policy recommendations on this subject.

Should pregnant women be vaccinated?

While pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy.

Pregnant women may receive the vaccine if the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks.

For this reason, pregnant women at high risk of exposure to SARS-CoV-2 (e.g. health workers) or who have comorbidities which add to their risk of severe disease, may be vaccinated in consultation with their health care provider.

Who should not take the vaccine?

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

The vaccine has only been tested in children above 16 years of age. Therefore, at this time, WHO does not recommend vaccination of children below 16 years of age, even if they belong to a high-risk group.

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.

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.

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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.

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