Thursday, April 8, 2021

Should Pregnant Women Take COVID Vaccine? Q&A With Dr Willis Akhwale

The chair of the Covid-19 vaccine task force, Dr Willis Akhwale, spoke to the Nation about the ongoing vaccination drive in Kenya.

1. Are there official Covid guidelines for pregnant and/or lactating women?
It’s important to note that indications on usage for any pharmaceutical products, including vaccines, depends a lot on what happens during trials. As you know, trials begin with animals before moving to humans and in the first instance, only a handful of individuals participate. From the information we have, the vaccines were not tried on pregnant and lactating women and, therefore, there was no information available for this demographic by the time we got emergency use authorisation. As a precaution for this group therefore, vaccination is not advised.

2. How many private hospitals have been issued with the vaccines?
Our health care system, as you know, is mixed with faith-based, private and public facilities working side by side. Because of the complexity of the rollout, we started our Covid-19 vaccination programme with few facilities overall and every week, we add to this number across the different players in the Health sector. Ultimately, we expect that most of our facilities in the health service mix will participate in the exercise once they have been prepared for it accordingly. In this first phase, we are targeting to have 300 private facilities participating. By the end of next week, 50 per cent of these will already be engaged. Training that has been undertaken by the ministry has included staff from these facilities.

3. India is now circling the wagons and restricting exports, the impact is beginning to be felt worldwide, particularly in poorer countries. Will this delay our plans to get the AstraZeneca vaccine in April as anticipated?
We have been informed that our consignment, which was due in early April, is now delayed but due in early May. Incidentally, this is the time that Kenyans who started receiving their first doses are due for their second dose. According to WHO recommendations, the second dose for Astrazeneca vaccine, which is what we are administering, can be given up to 12 weeks after the first dose. We have put in place plans to ensure everyone who got the first dose of AstraZeneca receives the second dose on time.

4. What arrangement is made for the priority workers who have not received the first dose and those who will get the second dose of the AstraZeneca vaccine?
As noted, second dose can be administered anywhere between 8 and 12 weeks after the first dose. Given that many are still yet to get their first dose, we expect that by the time we receive our next consignment, we shall still be within the correct window for administering the second doses. The global market is experiencing supply shortages due to the high demand for vaccines, but we are confident we shall be in schedule to administer the second doses and quickly make a transition to our second phase of deployment and vaccination.

5. What other vaccines is the government considering bringing to the country and at what stage are we on this front?
We are confident that vaccines present a good mitigation against Covid-19. The global community has moved with a lot of speed in developing viable vaccines to use against the disease. Many have already been produced and are already in the market while many others are in different stages of research and approvals by regulatory authorities. Our policy now is to only use vaccines which have approval by the World Health Organization and are registered by our Pharmacy and Poisons Board. Currently these include AstraZeneca, Pfizer and Moderna. Several others like Johnson and Johnson, Novavax, and Sinovac are currently under review. We are open to bringing any vaccines that become available through the Covax facility, Africa CDC platform, and where necessary, what we get through bilateral arrangements, but which satisfies the criteria already set.

6. Explain the confusion around Sputnik vaccine, is it authorised or not?
Sputnik V is a Russian-manufactured vaccine, which like most others, has received emergency use authorisation in many countries across the world. Our own Pharmacy and Poisons Board did also give it emergency use authorisation. But remember, in addition to our regulatory approvals, our criteria include receiving emergency use authorization by WHO. At the moment, the WHO is still reviewing the data submitted on this vaccine and it is yet to conclude the exercise and give its recommendations. Some private distributors, however, did bring the vaccine into the country and started administering it on Kenyans before this, and some other conditions, were met.

These other conditions include registration of vaccination sites with the Kenya Medical Practitioners’ and Dentists’ Council. In its meeting held on April 2, the National Emergency and Response Committee on coronavirus chaired by the Cabinet Secretary for Health reviewed emerging issues and concerns surrounding this vaccine and the overall participation of the private sector in the importation, distribution and administration of vaccines. The meeting resolved to ban the participation of the private sector in the importation, distribution and administration of vaccine until further notice. Could Sputnik be brought in by the government at a future date? absolutely, especially if it fulfills the criteria set.

7. In your assessments what is the progress of the vaccination drive countrywide?
We have made very good progress in our vaccination programme. Since this was a new vaccine, we ensured that even as we started the roll-out we had in place all regulatory requirements, including the monitoring of side effects. To ensure the quality of the vaccinations process, we ensured staff from all vaccination posts were adequately trained. The training was progressive. We started with 47 posts (one in each county) and have now trained staff of 658 posts who can now safely administer the vaccine. Indeed, during our first week of vaccination, our average daily vaccinations was 3,000, during the second week it was 5,000, the third week it was 12,000 and as of end of last week, we did some 40,000 vaccinations on Friday.

8. Will the ministry institute an equalisation model among counties especially those that exhausted their vaccines and those that have excess supply?
Distribution of vaccines followed analysis of frontline workers in all the counties. Remember these were our target. Now that the 58-year-olds and above were added to the first phase, we have to revise our matrix to cover these as well. Fortunately, our country has very robust population indicators to be relied upon. Beyond the initial distribution, however, our plan is to have a pull supply system in the end. Meaning you get replenishment upon adequately reporting utilisation through the Chanjo Ke system.

9. Comment on the fact that people who are not in the targeted groups jumped the queue?
We want to discourage this absolutely. I urge Kenyans to understand that we have global constraints in the supply of Covid-19 vaccines and the priority is to protect those at risk of infection (frontline workers) and those at risk of severe disease (those with underlying conditions and the elderly). After that, we plan to cover the general population. If one is not among the target population in our phased approach, they should understand and wait for their turn.

10. How long will it take before commercial vaccines are allowed?
At the moment this has been banned until when the necessary regulatory and accountability mechanism has been put in place. At the moment, we do not want to open a second window prone to abuse, for example, where the free of charge vaccines are sold by the private sector. It’s important to note that in a pandemic, it’s very easy for people to be taken advantage of. The government has a duty to protect the safety of its people and those resident in the country.



source http://nairobiwire.com/2021/04/should-pregnant-women-take-covid-vaccine-qa-with-dr-willis-akhwale.html

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