The World Health Organization (WHO) has backed the use of Pfizer Inc’s (Pfizer) oral COVID-19 antiviral treatment, Paxlovid, in high-risk patients in the early stages of the disease, to avoid hospitalisation. However, WHO is quick to mention that existing COVID-19 treatments including intravenous and antibody treatments, are not to replace vaccination.

The recommendation by WHO comes after an analysis of trial data by the United Nations agency showed incorporation of the Paxlovid treatment in 3,100 patients dramatically cuts the risk of hospitalisation. For those with over 10% risk of hospitalisation, using Paxlovid could lead to 84 fewer hospitalisations per 1,000 patients – an overall 85% reduction in risk.

“These therapeutics do not replace vaccination. They just give us another treatment option for those patients that do get infected that are at higher risk,” said Janet Diaz, Lead on Clinical Management, WHO, referring to patients who have underlying chronic conditions, or are immunocompromised or unvaccinated.

Pfizer expects Paxlovid to bring in US$22 billion in sales in 2022, according to a statement earlier this year. The drugmaker has agreed to sell up to 4 million treatment courses to UNICEF for use in 95 low-income countries that encompass just over half the world’s population. This deal accounts for just over 3% of Pfizer’s projected production of 120 million courses this year.

While recommended, Paxlovid is known to interact with many common medications, complicating its use. Paxlovid has also not been investigated for use in pregnant of breastfeeding women, or children.

Separately, the WHO has updated its recommendation on Gilead Science’s COVID-19 treatment, remdesivir, saying it should be used in mild or moderate COVID-19 patients at high risk of hospitalisation. It had previously recommended its use in all COVID-19 patients, regardless of disease severity.

Read: Pfizer, UNICEF to supply Paxlovid COVID-19 oral treatment for low-, middle-income countries

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Pfizer Inc. (Pfizer) has announced an agreement with UNICEF to supply nearly 4 million treatment courses of its COVID-19 oral treatment to 95 low- and middle-income countries. The COVID-19 oral treatment, Paxlovid (nirmatrelvir tablets and ritonavir tablets), will be given to all low-income and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa. Countries that have transitioned from lower-middle to upper-middle-income status in the last five years will be included as well.

Pfizer expects supply to be available to support orders as early as April 2022 – supply will continue throughout 2022, pending regulatory authorisation or approval and according to country needs.

Paxlovid is an orally administered SARS-CoV-2 protease inhibitor. It is prescribed at the first sign of infection or at first awareness of an exposure and so potentially helps patients avoid severe illness which can lead to hospitalisation and death) or avoid disease development following contact with a COVID-19-positive household member.

Paxlovid is to be administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice daily for five days. One treatment carton contains five blister packs of Paxlovid, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Nirmatrelvir [PF-07321332] is designed to inhibit or block the activity of an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir so it can remain active in the body for longer periods of time. Nirmatrelvir is safe and has shown consistent in vitro antiviral activity against earlier and current coronavirus variants of concern in preclinical studies.

“We have seen the negative impacts of COVID-19 in every part of the world and know that we must work towards access for all people regardless of where they live or their circumstances,” said Albert Bourla, Chairman and CEO, Pfizer. “Supplying to UNICEF is an important part of our comprehensive strategy to accelerate access to Paxlovid to treat COVID-19 infection as quickly as possible and at an affordable price in order to decrease the strain on healthcare systems and help save lives in low- and middle-income countries.”

*Pfizer will offer its oral therapy through a tiered pricing approach, pending country authorisation or approval, based on the income level of each country to promote equity of access across the globe. High and upper-middle income countries will pay more than lower income countries.

Read: FDA approves booster dose of Pfizer COVID-19 vaccine for US citizens

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This week, the US Food and Drug Administration (FDA) approved of a booster shot for the Pfizer-BioNTech (Pfizer) COVID-19 vaccine for at-risk individuals in the US. The FDA has amended the prior emergency use authorisation for Pfizer’s COVID-19 vaccine to now include a third booster dose to be given at least six months after the second dose; it will prioritise those over 65 and adults over 18 with health conditions putting them at high-risk of severe COVID-19.

The FDA’s booster decision includes a significant gray area in its third booster approval category – “individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19, including severe COVID-19.”

Acting FDA commissioner Janet Woodcock said this category could also include “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

Read: WHO Director-General “appalled” over global COVID-19 vaccine inequity

The Advisory Committee on Immunization Practices (ACIP) will decide what constitutes a “high-risk” individual and will offer their recommendations to the Centers for Disease Control and Prevention (CDC) at the soonest available date.

It is important to note that the FDA’s booster approval is limited to only the Pfizer COVID-19 vaccine, and offers no insight for Americans who previously received the Moderna or Johnson & Johnson vaccines. There is currently no advice or approval for booster shots for those vaccines, and there is no suggestion those who initially received the Pfizer vaccine can receive a booster of a different vaccine.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” added Woodcock. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

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The mRNA COVID-19 vaccine developed by pharmaceutical companies Pfizer and BioNTech late last year was advised to be kept at ultra-cold temperatures to prevent degradation – the ultra-cold storage requirement has inevitably been a difficult and expensive problem to overcome in many parts of the world.

However, new company data from Pfizer suggests its vaccine is stable for at least two weeks in more normal freezer temperatures of between -25 °C to -15 °C (-13 °F to 5 °F). This new data has been supplied to the U.S. Food and Drug Administration (FDA) in the hopes of updating the details of emergency use authorisation, shipping and storage methods of the vaccine.

CEO of BioNTech, Ugur Sahin, suggests this new recommendation has arisen out of continual stability studies that have been ongoing since mass production of the vaccine commenced late last year.

Read: Emergency use authorisation for Pfizer’s COVID-19 vaccine in India

[Standard pharmaceutical freezers deliver temperatures between -25 °C to -15 °C (-13 °F to 5 °F); ultra-cold freezers, on the other hand, can keep items at temperatures between -80 °C and -60 °C (-112 °F to ‑76 °F). Pfizer has been conservative with storage recommendations for its mRNA vaccine until further data could be collected.]

“Our top priority was to quickly develop a safe and effective vaccine and make it available to the most vulnerable people in the world in order to save lives,” said Sahin. “At the same time, we have continuously collected data that could enable storage at around -20 °C (-4 °F). The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centres an even greater flexibility.”

Closely following Pfizer’s emergency FDA approval last year was another mRNA vaccine from Moderna, which did not require the same degree of ultra-cold storage.

Moderna claims its unique lipid nanoparticle formulation in the vaccine allows for greater stability at higher temperatures compared to Pfizer’s candidate. Moderna has also garnered significant experience and insight over several years developing a number of other mRNA vaccines in various temperature conditions.

Peter English, former chair of the British Medical Association’s Public Health Medicine Committee, says it is possible Pfizer will broaden storage temperature requirements for its COVID-19 vaccine even further as it learns more over time.

“I would not be surprised if, as time goes by and the period of storage prior to testing increases, they will be able to increase this period,” says English. “This is likely to make the infrastructure requirements considerably easier.”

The first batch of the Pfizer-BioNTech COVID-19  vaccine arrived in Malaysia on Sunday – 312,390 doses that were flown to Kuala Lumpur International Airport (KLIA) in Sepang are part of a total of 32 million doses Malaysia is procuring from US pharmaceutical giant Pfizer Inc to battle the pandemic.

The next batch is scheduled to arrive on Friday, and subsequent shipments are expected to be delivered every two weeks.

Malaysia plans to begin inoculating its people against the coronavirus on Wednesday. According to the minister in charge of the national immunisation program, Khairy Jamaluddin, the inoculation program’s start has been brought forward by two days from Friday at the government’s discretion.

Health workers and other front-line workers will be inoculated in the first phase, including Prime Minister Muhyiddin Yassin. Senior citizens, high-risk groups, and those in the general public aged 18 and older will come after.

Foreigners, including undocumented migrants, will also be given shots free of charge. Khairy reiterated the government’s assurance that undocumented migrants would not be detained when they receive the vaccine.

The national immunisation program is expected to run through February 2022for its entire population of 32 million people, with vaccine supplies coming from Britain’s AstraZeneca Plc and companies in China and Russia.

Malaysia reported 3,297 new virus cases on Sunday, and has logged a total of 283,569 cases and 1,056 fatalities.

The Philippines has given the green light to Pfizer BioNTech’s Covid-19 vaccine for emergency use. According to Food and Drug Administration (FDA) Director-General Eric Domingo, the authorization was granted after a thorough review of currently available data by medical and regulatory experts.  

The Pfizer BioNTech Covid-19 vaccine, which based on Phase III trials data, has an efficacy rate of 95%; it is the first vaccine in the World Health Organization’s (WHO) emergency list. It means that the  Pfizer-BioNTech vaccine met WHO’s safety requirements; and that the vaccine’s benefits outweighed any potential risks.

The FDA received the US-based pharmaceutical company’s application for emergency use authorization (EUA) of its Covid-19 vaccine in the Philippines last December 23.  An EUA allows Pfizer’s vaccine to be imported and rolled out in the country via a national immunization program.

Meanwhile, the Philippines has reported its first case of the new coronavirus variant that was first detected in the UK. According to reports, the said patient, a resident of Quezon City, Metro Manila, had traveled from Dubai.

The World Health Organization (WHO) has listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago.

Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products hails it as “a very positive step towards ensuring global access to COVID-19 vaccines”, adding that  the need for an even greater global effort  is needed to achieve enough vaccine supply to meet the needs of priority populations everywhere.  WHO and its partners are working rigorously to evaluate other vaccines that have reached safety and efficacy standards, and are encouraging even more developers to come forward for review and assessment. 

Regulatory experts convened by WHO from around the world and WHO’s own teams reviewed the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis. The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks.

The vaccine is also under policy review.  WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE) will convene on 5 January 2021, to formulate vaccine-specific policies and recommendations for this product’s use in populations, drawing from the SAGE population prioritisation recommendations for COVID-19 vaccines in general, issued in September 2020.

Read: Experimental new vaccine blocks COVID-19 and other coronavirus variants

The Comirnaty vaccine requires storage using an ultra-cold chain; it needs to be stored at -60°C to -90°C degrees. This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible. For that reason, WHO is working to support countries in assessing their delivery plans and preparing for use where possible.

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines, and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy, and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks. Experts from individual national authorities participate in the EUL review. Once a vaccine has been listed for WHO emergency use, WHO engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.

As part of the EUL process, the company producing the vaccine must commit to continuing to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.